The Journal of Clinical Dentistry - #ColgateTalks...The Journal of Clinical Dentistry has been accepted for inclusion on MEDLINE, the BIOSIS, SCISEARCH, BIOMED and EMBASE databases,

SENIOR EDITORRobert C. Emling, EdD

EDITORIAL BOARDMartin Addy, BDS, MSc, PhD, FDSRCSCaren M. Barnes, RDH, MSAnnerose Borutta, Prof.Dr.med.habil.Robert L. Boyd, DDS, MEdKenneth H. Burrell, DDS, MSMark E. Cohen, PhDHeinz Duschner, Prof.Dr.William Michael Edgar, PhD, DDSc, FDSRCSDenise Estafan, DDS, MSJohn D.B. Featherstone, MSc, PhDStuart L. Fischman, DMDRosa Helena Miranda Grande, DDS, PhDJohn J. Hefferren, PhDElliot V. Hersh, DMD, PhDMark E. Jensen, DDS, PhDCarl J. Kleber, MSD, PhDIsrael Kleinberg, DDS, PhD, DScKarl F. Leinfelder, DDS, MSJohn H. Manhold, MA, DMDJonathan Mann, DMD, MScKenneth Markowitz, DDSMilton V. Marshall, PhD, DABTPier Francesco Porciani, MD, MScDHoward M. Proskin, PhDMark S. Putt, MSD, PhDBruce R. Schemehorn, MSWarren Scherer, DDSThomas Schiff, DMDJon B. Suzuki, DDS, PhD, MBAJason M. Tanzer, DMD, PhDNorman Tinanoff, DDS, MSHenry O. Trowbridge, DDS, PhDRichard I. Vogel, DMDJames S. Wefel, PhDAnthony E. Winston, BScWayne T. Wozniak, PhDStefan Zimmer, Priv.-Doz. Dr. med. dent.

PUBLISHERStephen M. Siegel

Special Issue

The

Journal ofClinical Dentistry®

THE INTERNATIONAL JOURNAL OF APPLIED DENTAL RESEARCH

www.JClinDent.comVolume XXI 2010 Number 4

Clinical Antiplaque andAntigingivitis Efficacy of

Two Dentifrices: Triclosan, Copolymer, and Sodium

Fluoride vs. Stannous Fluoride,Sodium Hexametaphosphate,

and Zinc Lactate

The Journal of Clinical Dentistry (ISSN 0895-8831) is published by Professional Audience Communications, Inc., P.O. Box 243, Yardley, PA 19067.POSTMASTER; Send address changes to P. O. Box 243, Yardley, PA 19067.

Copyright © 2010 by the YES Group, Inc. All rights reserved. No part of this publication may be reproduced without written permission from the publisher.

The Journal of Clinical Dentistry has been accepted for inclusion onMEDLINE, the BIOSIS, SCISEARCH, BIOMED and EMBASE databases,and the Automatic Subject Citation Alert.

The Journal of Clinical Dentistry is dedicated to the publication of significantclinical and applied dental research and reviews. All scientific studies publishedin this Special Issue have been reviewed and approved by members of theEditorial Board on the basis of clarity, scientific accuracy and the application ofacceptable standards for the research presented. The publication of these articlesin no way implies an endorsement of the products listed therein by The Journalof Clinical Dentistry, its Editors, Edi torial Board, or the Publisher.

The Journal of Clinical Dentistry is printed on recycled paper.

Member Publication

C

On the CoverArtist’s rendition demonstrating how the PVM/MAcopolymer facilitates the delivery and retention of

triclosan on the surfaces of teeth and gums.

Superior Management of Plaque and Gingivitis Throughthe Use of a Triclosan/Copolymer Dentifrice

Sebastian Ciancio, DDS

Distinguished Service Professor and Chair

Department of Periodontics and Endodontics

School of Dental Medicine, University at Buffalo, SUNY

Buffalo, NY, USA

Fotinos S. Panagakos, DMD, PhD

Director, Clinical Research Relations and Strategy

Colgate-Palmolive Technology Center

Piscataway, NJ, USA

(J Clin Dent 2010;21[Spec Iss]:93–95)

93

Periodontal disease is a continuum of oral diseases of polymi-

crobial origin, characterized by a bacterial plaque (biofilm)-

induced gingival inflammation which, if left untreated, may lead

to chronic infection and loss of attachment.1 The continuum of

disease begins with gingivitis, which is inflammation of the

gingiva in response to the bacterial biofilm on adjacent teeth.

Clinically, the gingival tissue can be characterized by erythema,

edema, and fibrous enlargement, and may bleed upon gentle

probing. This early stage of periodontal disease, while quite

prevalent in the general population, can be treated and prevented

with appropriate home and supportive professional care. How-

ever, even with professional care and reinforcement of daily

oral hygiene procedures, many patients continue to develop

gingivitis. These patients are, therefore, at greater risk of devel-

oping more severe forms of periodontal disease. Topical anti-

septics incorporated into dentifrices and mouthrinses may be of

special value to these patients.

The importance of bacterial plaque to the onset and progres-

sion of periodontal diseases is well-accepted.1 While more than

500 species of bacteria have been detected in the oral cavity, only

a minority of pathogenic species, such as the gram anaerobes

Veillonella species, Fusobacteria species, and Porphyromonas

gingivalis produce products that can adversely affect the adjacent

gingival tissues.2 Microbial products can either directly or indi-

rectly trigger a host soft tissue response by stimulating inflamma -

tory mediator production, increasing the levels of inflammatory

mediators within the gingival tissues, resulting in the presenta-

tion of clinical inflammation. Without intervention or treatment,

supporting tissues may be destroyed, clinical pockets may form,

bone resorption may occur, and ultimately, the tooth may be

lost. Potentially more serious than tooth loss is the possibility that

this local oral inflammatory process may negatively impact the

rest of the body’s immune response, and ultimately may affect

overall health.3

Given the complexity of periodontal diseases and the impor-

tance of oral health, one of the critical questions is how to best

prevent and treat periodontal infection. Professional procedures

such as dental prophylaxis and scaling/root planing provide clin-

ically proven and accepted benefits. Effective daily home oral

care can help maintain a healthy oral environment and decrease

the occurrence of oral disease. However, dental professionals

accept the fact that not all patients will consistently perform

home oral care procedures at an acceptable level. Therefore, the

dental profession will often recommend adjuncts to routine home

oral care, such as the use of a product which has clinically

proven anti plaque and antigingivitis properties, which may

provide a unique and beneficial approach to the prevention and

treatment of periodontal diseases via daily oral care procedures.

The delivery of an active ingredient with antiplaque and anti -

gingivitis benefits can be through a dentifrice or a mouthrinse.

The incorporation of such an ingredient into a dentifrice is a

particularly attractive option to augment mechanical cleaning

procedures, as dentifrices are typically used along with a tooth-

brush for routine oral hygiene. A unique dentifrice, Colgate®

Total® (Colgate-Palmolive Co., New York, NY, USA), has been

developed and clinically proven to provide antiplaque and anti -

gingivitis benefits when compared to a conventional fluoride

dentifrice.4 This dentifrice contains a broad-spectrum anti -

bacterial agent, triclosan, and a polyvinylmethyl ether/maleic

acid (PVM/MA) copolymer to ensure uptake and retention of

triclosan on the oral hard and soft tissues. Effective levels of

triclosan are retained in the oral cavity 12 hours after brushing the

teeth, allowing prolonged control of the oral bacteria that form

plaque, and can cause gingivitis, calculus, and oral malodor.4

Colgate Total also contains sodium fluoride at the maximum

regulated level (1000–1450 ppm) to deliver cavity protection.

This triclosan/copolymer/fluoride dentifrice has been proven to

deliver statistically significant and clinically relevant benefits in

the prevention of caries, the reduction of dental calculus buildup

and oral malodor, as well as the control of dental plaque and the

treatment of gingivitis.4 Independent reviews of the literature

have established that Colgate Total is effective in reducing the for-

mation of supragingival plaque, and for reducing the incidence of

gingivitis when compared to a conventional fluoride toothpaste.5-7

Colgate Total was the first, and remains the only toothpaste to

be approved by the US Food and Drug Administration (under

a new drug application process) and accepted by the American

Dental Association (ADA) to fight plaque and gingivitis. Perhaps

for this reason, Colgate Total is the toothpaste most often rec -

ommended and used by dentists and dental hygienists in the US.

94 The Journal of Clinical Dentistry Vol. XXI, No. 3

trolling Established Gingivitis and Supragingival Plaque,”14 and

“A Comparison of the Efficacy of a Triclosan/Copolymer/Sodium

Fluoride Dentifrice, a Stannous Fluoride/Sodium Hexameta -

phosphate/Zinc Lactate Dentifrice, and a Sodium Fluoride Den-

tifrice for the Control of Established Supragingival Plaque and

Gingivitis: A Six-Week Clinical Study”15 provide the results

from two separate six-week clinical studies.

The results from these two studies support the conclusion that

a dentifrice containing 0.3% triclosan/2.0% PVM/MA copoly-

mer/0.243% sodium fluoride is efficacious for the control of

established gingivitis and supragingival plaque as compared to

a conventional fluoride dentifrice, and that it provides a greater

level of efficacy for the control of gingivitis and supragingival

plaque than does a dentifrice containing 0.454% stannous fluo-

ride, sodium hexametaphosphate, and zinc lactate.

The final paper is titled “Comparative Investigation of the

Efficacy of Triclosan/Copolymer/Sodium Fluoride and Stannous

Fluoride/Sodium Hexametaphosphate/Zinc Lactate Dentifrices

for the Control of Established Supragingival Plaque and Gin-

givitis in a Six-Month Clinical Study.”16

The results of this study confirmed the outcomes demon-

strated in the two six-week clinical studies, that a dentifrice con-

taining 0.3% triclosan, 2.0% PVM/MA copolymer, and 0.243%

sodium fluoride provides a significant reduction in established

supragingival plaque and gingivitis compared to a dentifrice

containing 0.454% stannous fluoride, sodium hexametaphos-

phate, and zinc lactate when used over a period of six months.

In 2007, the ADA advised consumers that “use of an ADA-

Accepted antimicrobial mouthrinse or toothpaste helps prevent

and reduce plaque and gingivitis.”17 Based on this statement, it

is critical for dental professionals to know what products exist

that meet this advice, and to know which products are proven

most efficacious in reducing dental plaque and associated gin-

givitis, so that the public can receive the most beneficial effects

from daily brushing.

To meet this need, the oral healthcare profession needs evidence

to support a recommendation to their patients for the daily use of

a fluoride dentifrice that is supplemented by an antimicrobial/

antibacterial agent for the prevention of dental caries and gin-

givitis. The studies reported in this Special Issue demonstrate evi-

dence, using valid and robust in vitro, ex vivo, and in vivo meth-

ods, that a dentifrice containing 0.3% triclosan, 2.0% PVM/MA

copolymer, and 0.243% sodium fluoride (Colgate Total) provides

superior plaque and gingivitis reduction versus a dentifrice con-

taining 0.454% stannous fluoride, sodium hexametaphosphate,

and zinc lactate (Crest Pro-Health). Based on these studies, as

well as previous research, it is evident that Colgate Total will help

provide patients with the best protection against plaque and gin-

givitis when used as part of a daily oral hygiene regimen.

Acknowledgment: Publication of this review was supported by the Colgate-

Palmolive Company.

For further correspondence with the authors of this paper,

contact Dr. Fotinos Panagakos–[email protected].

References1. Gu Y, Ryan ME. Overview of periodontal diseases: pathogenesis, and char-

acteristics. In: Periodontal Disease and Overall Health: A Clinician’s Guide,

Similarly, it has been approved by regulatory authorities and

accepted by dental associations all around the world.

The scientific literature shows that dentifrices containing

0.454% stannous fluoride provide a benefit in reducing supragin-

gival plaque formation and the incidence of gingivitis.8,9 In 2006,

a dentifrice was introduced into the US marketplace claiming

antigingivitis efficacy. The dentifrice, Crest® Pro-Health® (Procter

& Gamble Co., Cincinnati, OH, USA) toothpaste, contains 0.454%

stannous fluoride, sodium hexametaphosphate, and zinc lactate.10

Stannous fluoride, like sodium fluoride, is an active ingredient

used in dentifrices to reduce caries.

The five articles which follow this Introduction present a

series of laboratory and patient-based studies that compare the

efficacy of a dentifrice containing 0.3% triclosan, 2.0% PVM/MA

copolymer, and 0.243% sodium fluoride (Colgate Total) to a den-

tifrice containing 0.454% stannous fluoride, sodium hexa meta -

phosphate, and zinc lactate (Crest Pro-Health) for the control of

established supragingival plaque and gingivitis. A brief review

of each of the five articles is provided, starting with a laboratory-

based investigation entitled “Evaluation of Antibacterial Activity

of Dentifrices on Human Oral Bacteria.”11

In vitro testing of antibacterial agents is an important tool in

the evaluation hierarchy, and may provide interesting insights

into their potential clinical efficacy. Agents with demonstrable

in vitro antibacterial activity may be effective against the same

microorganisms in vivo, whereas agents without demonstrable in

vitro antibacterial activity are unlikely to exhibit in vivo anti-

bacterial activity. In addition, these methods may also be useful

in screening antibacterial agents in product formulations be-

cause such agents with both in vitro and in vivo activity may have

reduced antibacterial effects when formulated into a dentifrice.

Accordingly, the first study in this Special Issue examined the

in vitro and ex vivo antimicrobial activity of dentifrices contain -

ing 0.454% stannous fluoride, sodium hexametaphosphate, and

zinc lactate, or 0.3% triclosan, 2.0% PVM/MA copolymer, and

0.243% sodium fluoride. The results of these studies indicate that

via different in vitro and ex vivo analyses, the dentifrice with 0.3%

triclosan, 2.0% PVM/MA copolymer, and 0.243% sodium flu-

oride has significant antibacterial activity on oral bacteria, in-

cluding species causing dental caries, periodontitis, and oral hal-

itosis, and provides superior efficacy compared to the 0.454%

stannous fluoride, sodium hexametaphosphate, and zinc lactate

dentifrice.

The second article, titled “Comparison of the Short-Term

Anti plaque/Antibacterial Efficacy of Two Commercial Denti-

frices,”12 provides a summary of three separate short-term clin-

ical studies which compared Colgate Total to Crest Pro-Health

on the forma tion of dental plaque over a 24-hour period of time.

These studies utilized the Modified Gingival Margin Plaque

Index (MGMPI), a validated and reliable clinical method for

assessing the efficacy of products in reducing plaque build up.13

In all three clinical trials, Colgate Total significantly reduced plaque

regrowth over a 24-hour time period compared to Crest Pro-

Health, and demonstrated that Colgate Total delivers a superior

antiplaque benefit over Crest Pro-Health after a single brushing.

The next two articles, titled “A Clinical Investigation of the

Efficacy of Three Commercially Available Dentifrices for Con-

Genco RJ, Williams RC, eds., Professional Audience Communications,

Yardley, PA, pp. 5-23, 2010.

2. Socransky SS, Haffajee AD. The nature of periodontal diseases. Ann Perio -

dontol 1997;2:3-10.

3. Williams RC, Barnett AH, Claffey N, Davis M, Gadsby R, Kellett M, Lip

GY, Thackray S. The potential impact of periodontal disease on general

health: A consensus view. Curr Med Res Opin 2008;24:1635-1643.

4. Panagakos F, Volpe AR, Petrone ME, DeVizio W, Davies RM, Proskin

HM. Advance oral antibacterial/anti-inflammatory technology: A compre-

hensive review of the clinical benefits of a triclosan/copolymer/fluoride

dentifrice. J Clin Dent 2005;16(Suppl):S1-19.

5. Davies RM, Ellwood RP, Davies GM. The effectiveness of a toothpaste con-

taining triclosan and polyvinylmethyl ether/maleic acid copolymer in im-

proving plaque control and gingival health. A systematic review. J Clin

Perio dontol 2004;31:1029-1033.

6. Gunsolley JC. A meta-analysis of six-month studies of antiplaque and

antigingivitis agents. J Am Dent Assoc 2006;137:1649-1657.

7. Blinkhorn AS, Bartold PM, Cullinan MP, Madden TE, Marshall RI, Raphael

SL, Seymour GJ. Is there a role for triclosan/copolymer toothpaste in the

management of periodontal disease? Br Dent J 2009;207:117-125.

8. Paraskevas S. Randomized controlled clinical trials on agents used for

chemical plaque control. Int J Dent Hyg 2005;3:162-178.

9. Paraskevas S, van der Weijden GA. A review of the effects of stannous

fluoride on gingivitis. J Clin Periodontol 2006;33:1-13.

10. Mankodi S, Bartizek RD, Winston RL, Biesbrock AR, McClanahan SF, He

T. Anti-gingivitis efficacy of a stabilized 0.454% stannous fluoride/sodium

hexametaphosphate dentifrice: A controlled 6-month clinical trial. J Clin

Perio dontol 2005;32:75-80.

11. Haraszthy VI, Zambon JJ, Sreenivasan PK. Evaluation of the antimicrob -

ial activity of dentifrices on human oral bacteria. J Clin Dent

2010;21(Spec Iss):

96-100.

12. Barnes VM, Richter R, DeVizio W. Comparison of the short term anti -

plaque/antibacterial efficacy of two commercial dentifrices. J Clin Dent

2010;21(Spec Iss):101-104.

13. Xu T, Barnes VM. The development of a new dental probe and a new

plaque index. J Clin Dent 2003;14:93-97.

14. Singh S, Chaknis P, DeVizio W, Petrone M, Panagakos FS, Proskin HM.

A clinical investigation of the efficacy of three commercially available

dentifrices for controlling established gingivitis and supragingival plaque.

J Clin Dent 2010;21(Spec Iss):105-110.

15. Ayad F, Stewart B, Zhang YP, Proskin HM. A comparison of the efficacy

of a triclosan/copolymer/sodium fluoride dentifrice, a stannous fluoride/

sodium hexametaphosphate/zinc lactate dentifrice, and a sodium fluoride

dentifrice for the control of established supragingival plaque and gingivi-

tis: A six-week clinical study. J Clin Dent 2010;21(Spec Iss):111-116.

16. Boneta AE, Aguilar MM, Romeu FL, Stewart B, DeVizio W, Proskin HM.

Comparative investigation of the efficacy of triclosan/copolymer/sodium

fluoride and stannous fluoride/sodium hexametaphosphate/zinc lactate

dentifrices for the control of established supragingival plaque and gin gi -

vitis in a six-month clinical study. J Clin Dent 2010;21(Spec Iss):117-123.

17. American Dental Association news release, May 23, 2007.

Vol. XXI, No. 3 The Journal of Clinical Dentistry 95

Evaluation of the Antimicrobial Activity of Dentifriceson Human Oral Bacteria

Violet I. Haraszthy, MS, DDS, PhD Joseph J. Zambon, DDS, PhD

School of Dental Medicine, University at Buffalo

Buffalo, NY, USA

Prem K. Sreenivasan, PhD


Piscataway, NJ, USA

Abstract• Objective: In vitro testing of antimicrobial agents is an important tool in the testing hierarchy, and may provide interesting insights

into their potential clinical efficacy. Agents with demonstrable in vitro antimicrobial activity may be effective against the same micro -

organisms in vivo, whereas agents without demonstrable in vitro antimicrobial activity are unlikely to exhibit in vivo antimicrobial

activity. In addition, these methods may also be useful in screening antimicrobial agents in product formulations because such agents

with both in vitro and in vivo activity may have reduced antimicrobial effects when formulated into a dentifrice. Accordingly, this

study examined the in vitro and ex vivo antimicrobial activity of three commercial dentifrices: one formulated with 0.243% sodium

fluoride (Crest® Cavity Protection Toothpaste-Regular); one with 0.454% stannous fluoride, sodium hexametaphosphate, and zinc

lactate (Crest® Pro-Health®), and one with 0.3% triclosan, 2.0% PVM/MA copolymer, and 0.243% sodium fluoride (Colgate® Total®).

• Methods: The minimum inhibitory concentration (MIC) of each dentifrice was determined for resident oral bacterial species, in-

cluding bacteria that are associated with dental caries, periodontitis, and oral halitosis. Evaluations were performed on individual

laboratory strains, and on oral bacteria from supragingival plaque samples obtained from 10 adults and from oral rinse samples obtained

from 18 adults.

• Results: The lowest MICs against the oral strains and human samples, i.e., greatest antimicrobial activity, were seen for the triclosan/

copolymer dentifrice. There was, in general, a four-fold difference in MICs between the triclosan/copolymer dentifrice and the stannous

fluoride/sodium hexametaphosphate/zinc lactate dentifrice. The triclosan/copolymer dentifrice significantly inhibited periodontal

pathogens, such as Aggregatibacter actinomycetemcomitans, Eikenella corrodens, and Fusobacterium nucleatum. In ex vivo tests

measuring antimicrobial effects, the triclosan/copolymer dentifrice substantially inhibited bacterial growth after 30-, 60-, and 120-

second exposures compared to the sodium fluoride or stannous fluoride/sodium hexametaphosphate/zinc lactate dentifrices. Similarly,

in ex vivo tests measuring antimicrobial effects on supragingival plaque biofilms, the triclosan/copolymer dentifrice substantially

inhibited bacterial growth compared to the other test dentifrices.

• Conclusion: Different in vitro and ex vivo analyses show that the triclosan/copolymer dentifrice has significant antimicrobial activity

on oral bacteria, including species causing dental caries, periodontitis, and oral halitosis, and it provides superior efficacy compared

to the stannous fluoride/sodium hexametaphosphate/zinc lactate dentifrice.


96

IntroductionA variety of microbiological techniques have been used to

identify and characterize the microorganisms residing in the hu-

man oral cavity. This is an important activity in order to further

knowledge of the microorganisms that colonize the human body,

the microbiome,1 because oral microorganisms can cause dental

caries and periodontal disease, the most common infectious dis-

eases in man. Ninety-two percent of people in the US 65 years

of age and older have dental caries in their permanent teeth,2

50.3% of people in the US population 30 years or older have gin-

givitis,3 and 26% have destructive periodontitis.4 Microscopy,

bacterial culture, and, most recently, nucleic acid sequencing

are routinely used to identify microorganisms.5 Microbial sus-

ceptibility to antimicrobial agents is routinely evaluated by disk

diffusion assays (Kirby-Bauer), broth and agar dilution assays,

and combination assays, such as the spiral gradient endpoint

method and E test.5,6

Microbial susceptibility tests have obvious clinical applications

in the prevention and treatment of infectious diseases.5,6 Of par-

ticular interest is the correlation between in vitro antimicrobial

testing and in vivo efficacy. An agent that does not exhibit in vitro

antimicrobial activity is unlikely to demonstrate in vivo anti -

microbial activity. On the other hand, an antimicrobial agent that

demonstrates significant in vitro antimicrobial activity may or

may not exert similar levels of in vivo antimicrobial activity.

These levels are typically expressed as the minimum inhibitory

concentration (MIC) or the minimum bactericidal concentration

(MBC).7 The MIC is the lowest concentration of a drug that in-

hibits growth, while the MBC is the lowest concentration that kills

a microorganism. MICs are used to determine susceptibility or re-

sistance of microorganisms to an antimicrobial agent, i.e., what

kind and how much of an antimicrobial agent to use in a partic-

ular clinical situation. Antibiotic breakpoints are defined based on

the MIC and on the pharmacokinetics in healthy volunteers.5,6


slurry for 30, 60, or 120 seconds, and distributed onto solid

media containing defibrinated sheep blood.

The study protocol was approved by the Health Sciences

Institutional Review Board at the University at Buffalo.

Statistical AnalysisViable microorganisms recovered after antimicrobial treat-

ments were evaluated by ANOVA and Tukey multiple compar-

ison tests, with subjects and dentifrice in the model. Treatment

effects are reported as significant at p < 0.05.

ResultsThe TCN/C dentifrice demonstrated significantly higher anti -

microbial activity (Table I) than the other two dentifrices, with

MICs to oral bacteria ranging from less than 0.94 μg/mL to 30

μg/mL. By comparison, there were higher MICs for the SnF2

dentifrice, ranging from 1.8 to 75 μg/mL. There was especially

notable antimicrobial activity for the TCN/C dentifrice toward

perio dontal pathogens, including Aggregatibacter actinomycetem -

comitans, Campylobacter, Eikenella corrodens, and Fusobac-

terium nucleatum. For the SnF2

dentifrice, the highest MICs were

to Capnocytophaga gingivalis and Actinomyces meyerii, but were

otherwise similar to the F dentifrice for most of the gram-positive

and gram- negative test microorganisms.

In this study, the MICs for commercial dentifrices formulated

with stannous fluoride/sodium hexametaphosphate/zinc lactate,

triclosan/copolymer/sodium fluoride, and sodium fluoride were

determined for microorganisms commonly found in the human

oral cavity, using both laboratory strains and samples obtained

from adult subjects to determine the effects of different treatment

durations on microbial viability.

Materials and MethodsMedia, Chemicals, and Reagents

Bacteriological media were obtained from Becton-Dickinson

(Sparks, MD, USA) and formulated in accordance with manu-

facturer’s instructions. Buffers, chemicals, and laboratory

reagents were obtained from Sigma Chemical Company (St.

Louis, MO, USA) unless otherwise indicated.

Bacterial StrainsOral bacteria were obtained from either the American Type

Culture Collection (Manassas, VA, USA) or from the University

at Buffalo School of Dental Medicine (Buffalo, NY, USA), and

included oral and non-oral bacteria that can cause periodontal

disease, dental caries, or oral halitosis. All bacteria were cultured

on enriched tryptic soy agar, supplemented with 5% defibrinated

sheep blood, 5.0 µg/mL hemin, and 0.5 µg/mL vitamin K1.

DentifricesCommercially available dentifrices for this investigation in-

cluded a 0.243% sodium fluoride toothpaste (Crest® Cavity Pro-

tection Toothpaste-Regular, Procter & Gamble, Cincinnati, OH,

USA; henceforth F), a 0.454% stannous fluoride, sodium hexa-

metaphosphate, and zinc lactate toothpaste (Crest Pro-Health®,

Procter & Gamble, Cincinnati, OH, USA; henceforth SnF2), and

a toothpaste containing 0.3% triclosan, 2.0% polyvinylmethyl

ether maleic acid (PVM/MA) copolymer, and 0.243% sodium

fluoride (Colgate® Total®, Colgate-Palmolive Company, New

York, NY; henceforth TCN/C).

Laboratory TestsBacteria were tested against the F, SnF

2, and TCN/C tooth-

pastes, each dispersed in sterile water. Various dilutions of tooth-

paste slurries were incubated with bacteria cultured in liquid

media, and the MIC was defined as the lowest concentration

(highest dilution) in which the bacteria failed to grow. Positive

controls included bacteria without toothpaste slurry, and negative

controls included toothpaste slurry without added bacteria.

Ex Vivo TestsSupragingival plaque was collected from 10 adults, dispersed

by sonication, and distributed onto solid media containing de-

fibrinated sheep blood with different concentrations of tooth-

paste. Following anaerobic incubation at 37°C for five days, the

number of viable bacteria (CFU/mL) were enumerated from the

solid media. Oral rinse samples were obtained from 18 adults

follow ing informed consent and a one-week “washout” with a

commercially available fluoride dentifrice. The subjects rinsed

with 10 mL of sterile water for 10 seconds and expectorated into

sterile tubes. The oral rinse samples were mixed with toothpaste

Table I

Minimum Inhibitory Dentifrice Concentrations

Crest Crest CavityStrain Colgate Pro- Protection-

Bacterial Species Number Total Health Regular

Oral and Non-oral Microorganisms

Actinomyces meyerii ATCC 33972 15 75 30

Actinomyces viscosus ATCC 43146 7.5 7.5 30

Bacillus cereus ATCC 11778 7.5 15 30

Bacillus subtilis ATCC 6051 15 >150> 75

Candida albicans ATCC 90028 30 150 75

Escherichia coli ATCC 4157 7.5 150 >150>

Moraxella catarrhalis ATCC 8176 .< 0.94> 3.5 7.5

Staphylococcus aureus ATCC 6538 15 30 30

Veillonella dispar ATCC 17748 15 30 75

Veillonella atypica ATCC 27215 7.5 7.5 15

Periodontal Pathogens

Aggregatibacter.

actinomycetemcomitans ATCC 43717 < 0.94> 3.5 30

Aggregatibacter

actinomycetemcomitans ATCC 43718 1.8 3.5 30

Capnocytophaga gingivalis ATCC 33124 3.5 75 15

Campylobacter rectus ATCC 33238 1.6 7.5 15

Eikenella corrodens ATCC 23834 .< 0.94> 15 30

Fusobacterium nucleatum ATCC 25586 1.8 7.5 15

Porphyromonas gingivalis ATCC 53977 1.8 1.8 15

Prevotella intermedia ATCC 25611 3.5 3.5 15

Prevotella melanogenica ATCC 25845 3.5 3.5 30

Prevotella nigresence NCTC 9336 1.8 1.8 15

Cariogenic Bacteria

Streptococcus mutans ATCC 6538 7.5 7.5 30

Streptococcus gordonii ATCC 10558 3.5 7.5 15

Oral Halitosis-Causing Bacteria

Solobacterium moorei J10654 30 30 30


Figure 1 shows individual reductions in supragingival plaque

bacteria for each active formulation compared to the F dentifrice

in 10 subjects. For all subjects, the greatest reductions were for the

TCN/C dentifrice compared to the SnF2

dentifrice. In the latter,

five of 10 subjects showed increases in the number of supragin-

gival plaque bacteria as compared to the F dentifrice. Treatment

with the TCN/C dentifrice demonstrated significant reductions

in the number of supragingival plaque bacteria from all samples

when compared to the F dentifrice.

Figure 2 shows the average reduction in the number of supragin-

gival plaque bacteria for each test dentifrice compared to the F den-

tifrice for the 10 test subjects. For the SnF2

dentifrice group, the

average reduction was less than 3 � 105 viable colony forming units

per ml, while for the group using the TCN/C denti frice the average

reduction was greater than 4.5 � 107 colony forming units per ml.

Figure 3 shows the log transformed number of colony form-

ing units per ml recovered after treatment with the F, SnF2, or

TCN/C dentifrices for the 10 test subjects; that is, the remaining

number of supragingival plaque bacteria. The group treated with

the TCN/C dentifrice exhibited the lowest mean number of re-

maining supragingival plaque bacteria, approximately 6.7 Log10

CFU/ml, while those treated with the SnF2

and the F dentifrices

exhibited approximately 7.7 Log10

CFU/ml after treatment.

Average microbial viability after 30-, 60-, and 120-second

exposures of oral rinse samples from the 18 adults is shown in

Figures 4–6. After thirty seconds of dentifrice treatment (Figure

4) on oral bacteria collected from 18 adult volunteers, the lowest

numbers of viable bacteria were seen in the samples treated with

the TCN/C dentifrice, approximately 5.2 Log10

CFU/ml com-

pared to approximately 6.1 Log10

CFU/ml and 6.1 Log10

CFU/ml

for the SnF2

and the F dentifrices, respectively. For sixty seconds

of dentifrice treatment (Figure 5), the lowest numbers of viable

bacteria were also seen in the samples treated with the TCN/C

dentifrice, approximately 5.2 Log10

CFU/ml compared to ap-

proximately 6.1 Log10


CFU/ml for the

SnF2 and the F dentifrices, respectively. For 120 seconds of den-

tifrice treatment (Figure 6), the lowest numbers of viable bacteria

were again seen in the samples treated with the TCN/C dentifrice,

approximately 4.6 Log10

CFU/ml compared to approximately 5.9

Log10


CFU/ml for the SnF2

and F

dentifrices, respectively.

Figure 2. Average reductions in supragingival plaque bacteria for Crest Pro-

Health and Colgate Total from the Crest Cavity Protection Toothpaste-Regular

toothpaste. Graph indicates average reductions ± standard deviation (� 104

CFU/ml) from 10 subjects.

Figure 3. Effect of treatment with Crest Cavity Protection Toothpaste-Regular,

Crest Pro-Health, or Colgate Total on supragingival plaque bacteria from 10

subjects. Box-plots indicate viable supragingival plaque bacteria recovered

(Log CFU/ml) after each treatment. Horizontal line in box-plot is the median and

symbol represents the average.

Figure 1. Effect of treatment by Crest Pro-Health and Colgate Total on supragingi -

val plaque bacteria in comparison to Crest Cavity Protection Toothpaste-Regular.

Bars indicate reductions (a negative value) or increments (a positive value) in viable

organisms (� 104 CFU/ml) from 10 subjects.

Crest Pro-Health

Colgate Total

5000

2500

0

–2500

–5000

–7500

–10000

Figure 4. Effect of 30-second dentifrice treatments on oral organisms. Box-plots

indicate viable organisms recovered (Log CFU/ml) from 18 subjects after each

treatment. Horizontal line in box-plot is the median and symbol represents the

average.

Reductions in Organisms (CFU

/ml)

Viable supragingival plaque bacteria (Log CFU

/ml)

I I I I I I I I I I

1 2 3 4 5 6 7 8 9 10Subjects

ColgateTotalCrest Pro-Health

8.0

7.5

7.0

6.5

6.0

5.5

Colgate Total Crest Cavity Protection Regular Crest Pro-Health

Treatment


Two-way ANOVA at 30-, 60-, and 120-second treatment

durations of oral rinse samples showed subjects and dentifrices

were statistically significant (p < 0.0005). The TCN/C dentifrice

was more effective than the other two dentifrices at both the 30-

and 60-second post-treatment assessments (p < 0.0005), and the

F dentifrice more effective than the SnF2

dentifrice (p = 0.0001)

at the 60-second post-treatment assessment. The TCN/C denti-

frice was more effective at 120 seconds post-treatment than the

other two dentifrices (p < 0.0005), but the F dentifrice was not

significantly different from the SnF2

dentifrice (p = 0.058).

Two-way ANOVA with subject and dentifrice as effects was

used to examine microbial viability of the supragingival plaque

samples following treatment, and while each dentifrice demon-

strated significant effects (p < 0.0005), the TCN/C dentifrice

demonstrated the greatest effect. It also demonstrated sig -

nificantly higher bacterial growth inhibition by post hoc Tukey

multiple comparison tests than the other dentifrices (p < 0.0005).

There was no significant difference between the SnF2 and F den-

tifrices (p = 0.99).

DiscussionThis study examined the in vitro antimicrobial effects of three

different commercially available toothpastes utilizing labora-

tory strains of oral and non-oral bacteria, and bacteria from

supragingival plaque samples and oral rinse samples from adult

volunteers. Use of well-characterized laboratory strains enables

comparisons between antimicrobial tests performed at different

times in the same laboratory, or performed in different labora-

tories.6 The use of bacteria obtained from supragingival plaque

samples and from oral rinse samples recently obtained from hu-

man volunteers facilitates testing of “wild-type” bacterial strains

that often differ significantly from laboratory strains in terms of

virulence factors and pathogenicity.8 Bacteria in biofilms, such

as dental plaque, are much less susceptible to antimicrobial

agents, and demonstrate considerable physiologic variations

within their organized structure compared to planktonic organ-

isms.8,9 For example, fresh isolates of Aggregatibacter actino-

mycetemcomitans grow as rough adherent colonies in broth

media, while laboratory strains grow as smooth, non-adherent

colonies.10 Even strains of the same bacterial species isolated at

the same time from the same individual, such as Veillonella,

Porphyromonas gingivalis and streptococci, differ with regard to

antimicrobial susceptibility and virulence.11,12 The use of oral

rinse and dental plaque samples also facilitates identification of

bacteria with intermediate susceptibility, or that are resistant to

specific concentrations of dentifrice incorporated into the media.

Nonetheless, in vitro testing in the present study was consistent

in demonstrating significantly greater in vitro activity of the

triclosan-containing dentifrice compared to the other two tooth-

pastes, and in predicting clinical efficacy in inhibiting dental

plaque and other oral bacteria. Differences between the F and

SnF2

toothpastes were less notable at post-treatment evaluations.

The prediction of clinical efficacy derived from the in vitro

testing has been confirmed in a number of published clinical

trials showing that Colgate Total reduces dental plaque and

associated gingival inflammation. Fifteen published studies

involving 2,500 patients7,13-26 found that Colgate Total was highly

effective in reducing dental plaque and gingivitis. Reductions in

dental plaque are reported to be as high as 59%, while reductions

in gingivitis are reported to be as high as 51% compared to a reg-

ular fluoride dentifrice. For example, a random, double-blind,

three-year clinical study by Rosling, et al.,16 examining the sub-

gingival microbiota of adults with recurrent advanced peri-

odontitis, found a significant reduction in the number of viable

bacteria and probing pocket depth in subjects using Colgate

Total. A random, double-blind, clinical study by Deasy, et al.,17

examining the effect of Colgate Total on plaque and gingivitis in

139 subjects, found a nearly 19% reduction in supragingival

plaque and a 17% reduction in gingivitis in 139 subjects after

three months of use, and a 32% reduction in supragingival plaque

and a 26% reduction in gingivitis in 121 subjects after six months

of use. A six-month, double-blind clinical study by Bolden, et al.24

of 325 subjects found a 17% reduction in plaque and a 29%

reduction in gingival inflammation in 155 subjects using Colgate

Total, compared to 155 subjects using a control dentifrice. Thus

for TCN/C, in vitro antimicrobial testing, demonstrating the

inhibition of oral bacteria, was predictive of significant clinical




average.




average.


efficacy in inhibiting dental plaque and plaque-related gingival

inflammation in human subjects.

SummaryColgate Total, a dentifrice containing 0.3% triclosan, 2.0%

copolymer, and 0.243% sodium fluoride, demonstrated the best

broad-spectrum antimicrobial activity, that was approximately

four-fold better than Crest Cavity Protection Toothpaste- Regular,

a dentifrice formulated with 0.243% sodium fluoride, and Crest

Pro-Health, a dentifrice formulated with 0.454% stannous fluo-

ride, sodium hexametaphosphate, and zinc lactate. Colgate Total

significantly inhibited a variety of oral bacteria, including peri-

odontal pathogens such as Aggregatibacter actinomycetem -

comitans, Eikenella corrodens, and Fusobacterium nucleatum,

cariogenic bacteria such as mutans streptococci, and bacteria-

causing oral halitosis such as Solobacterium moorei. In addition

to its broad-spectrum antimicrobial activity against laboratory

strains of bacteria, Colgate Total demonstrated a substantially

greater broad-spectrum inhibition of bacteria from oral rinse

and dental plaque samples from adult subjects when compared

to the Crest Cavity Protection Toothpaste-Regular or Crest Pro-

Health toothpastes.

In summary, results from in vitro and ex vivo testing demon-

strate that Colgate Total had significantly better antimicrobial

activity on oral bacteria, including species causing dental caries,

periodontitis, and oral halitosis.

Acknowledgment: This study was supported the Colgate- Palmolive Company.


contact Dr. Joseph J. Zambon–[email protected].

References1. NIH Human Microbiome Project, http://nihroadmap.nih.gov/hmp/.

2. NIDCR website, Dental caries in permanent (adult) teeth. http://www.nidcr.

nih.gov/DataStatistics/FindDataByTopic/DentalCaries/DentalCariesAdults

20to64.htm.

3. NIDCR/CDC Dental, Oral and Craniofacial Data Resource Center, Oral Health,

U.S. 2002 Annual Report, Section 3: Periodontal disease. http://drc.hhs.gov/

report/3_1.htm.

4. NIDCR/CDC Dental, Oral and Craniofacial Data Resource Center, Data

Tables for Oral Health Indicators, http://drc.hhs.gov/report/dqs_tables/dqs_

3_2_1.htm.

5. Murray PR. Manual of Clinical Microbiology, 9th Ed. ASM Press, Herndon,

VA, 2007.

6. Jorgensen JH, Ferraro MJ. Antimicrobial susceptibility testing: a review of gen-

eral principles and contemporary practices. Clin Infect Dis 2009;49:1749-1755.

7. Garcia-Godoy F, Garcia-Godoy F, DeVizio W, Volpe AR, Ferlauto RJ,

Miller JM. Effect of a triclosan/copolymer/fluoride dentifrice on plaque

formation and gingivitis: A 7-month clinical study. Am J Dent 1990;3:S15-S26.

8. Fux CA, Shirtliff M, Stoodley P, Costerton JW. Can laboratory reference

strains mirror “real-world” pathogenesis? Trends Microbiol 2005;13:58-63.

9. Schaudinn C, Gorur A, Keller D, Sedghizadeh PP, Costerton JW. Perio -

dontitis: An archetypical biofilm disease. J Am Dent Assoc 2009;140:978-986.

10. Zambon JJ. Actinobacillus actinomycetemcomitans in human periodontal

disease. J Clin Periodontol 1985;12:1-20.

11. Jain S, Darveau RP. Contribution of porphyromonas gingivalis lipopolysac-

charide to periodontitis. Periodontol 2000 2010;54:53-70.

12. Beighton D. The complex oral microflora of high-risk individuals and

groups and its role in the caries process. Community Dent Oral Epidemiol

2005;33:248-255.

13. Gaffar A, Nabi N, Kashuba B, Williams M, Herles S, Olsen S, Afflitto J.

Anti plaque effects of dentifrices containing triclosan/copolymer/NaF system

versus triclosan dentifrices without the copolymer. Am J Dent 1990;3:S7-

S14.

14. Denepitiya JL, Fine D, Singh S, DeVizio W, Volpe AR, Person P. Effect upon

plaque formation and gingivitis of a triclosan/copolymer/fluoride denti-

frice: A 6-month clinical study. Am J Dent 1992;5:307-311.

15. Sharma NC, Galustians HJ, Qaquish J, Galustians A, Rustogi KN, Petrone

ME, Chaknis P, Garcia L, Volpe AR, Proskin HM. The clinical effectiveness

of a dentifrice containing triclosan and a copolymer for controlling breath

odor measured organoleptically twelve hours after tooth brushing. J Clin

Dent 1999;10:131-134.

16. Rosling B, Dahlén G, Volpe A, Furuichi Y, Ramberg P, Lindhe J. Effect of

triclosan on the subgingival microbiota of periodontitis-susceptible sub-

jects. J Clin Perio dontol 1997;24:881-887.

17. Deasy MJ, Singh SM, Rustogi KN, Petrone DM, Battista G, Petrone ME,

Volpe AR. Effect of a dentifrice containing triclosan and a copolymer on

plaque formation and gingivitis. Clin Prev Dent 1991;13:12-19.

18. Mankodi S, Walker C, Conforti N, DeVizio W, McCool JJ, Volpe AR. Clin-

ical effect of a triclosan-containing dentifrice on plaque and gingivitis: A six-

month study. Clin Prev Dent 1992;14:4-10.

19. Svatun B, Saxton CA, Huntington E, Cummins D. The effects of three silica

dentifrices containing triclosan on supragingival plaque and calculus for-

mation and on gingivitis. Int Dent J 1993;43:441-452.

20. Palomo F, Wantland L, Sanchez A, Volpe AR, McCool J, DeVizio W. The

effect of three commercially available dentifrices containing triclosan on

supragingival plaque formation and gingivitis: a six month clinical study. Int

Dent J 1994;44:75-81.

21. Barnes VM, Richter R, Vandeven M, Xu T, DeVizio W. Clinical investiga-

tion of the antiplaque efficacy of a new variant of a commercially available

triclosan/copolymer/fluoride dentifrice. J Clin Dent 2008;19:81-84.

22. Mateu FA, Boneta AE, DeVizio W, Stewart B, Proskin HM. A clinical in-

vestigation of the efficacy of two dentifrices for controlling established

supragingival plaque and gingivitis. J Clin Dent 2008;19:85-94.

23. Cubells AB, Dalmau LB, Petrone ME, Chaknis P, Volpe AR. The effect of

a triclosan/copolymer/fluoride dentifrice on plaque formation and gingivi-

tis: A six-month clinical study. J Clin Dent 1991;2:63-69.

24. Bolden TE, Zambon JJ, Sowinski J, Ayad F, McCool JJ, Volpe AR, DeVizio

W. The clinical effect of a dentifrice containing triclosan and a copolymer

in a sodium fluoride/silica base on plaque formation and gingivitis: A six-

month clinical study. J Clin Dent 1992;3:125-131.

25. Renvert S, Birkhed D. Comparison between 3 triclosan dentifrices on plaque,

gingivitis and salivary microflora. J Clin Periodontol 1995;22:63-70.

26. Triratana T, Rustogi KN, Volpe AR, DeVizio W, Petrone M, Giniger M. Clin-

ical effect of a new liquid dentifrice containing triclosan/copolymer on ex-

isting plaque and gingivitis. J Am Dent Assoc 2002;133:219-225.

27. Hu D, Zhang J, Wan H, Zhang Y, Volpe AR, Petrone ME. Efficacy of a

triclosan/copolymer dentifrice in the control of plaque and gingivitis: A six-

month study in China. Hua Xi Kou Qiang Yi Xue Za Zhi 1997;15:333.

Comparison of the Short-Term Antiplaque/Antibacterial Efficacyof Two Commercial Dentifrices

Virginia Monsul Barnes, DDS, MS Rose Richter, AAS

William DeVizio, DMD


Piscataway, NJ, USA

Abstract• Objective: The objective of these three clinical trials was to compare the impact of two commercial products, Colgate® Total® and

Crest® Pro-Health®, on the formation of dental plaque over a 24-hour period of time. The studies utilized the Modified Gingival

Margin Plaque Index (MGMPI), a validated and reliable clinical method for assessing the efficacy of products in reducing plaque

build-up.

• Methods: Colgate Total and Crest Pro-Health were the test products for all three clinical trials. Colgate® Great Regular Flavor (CR)

was used as the universal washout product. Colgate Total, as the only toothpaste approved by the FDA under an NDA for antiplaque,

antigingivitis, and anticaries benefits, contains 0.3% triclosan/2.0% PVM/MA copolymer for antigingivitis and antiplaque, as well

as 0.243% sodium fluoride (NaF) for anticaries. Crest Pro-Health contains 0.454% stannous fluoride (SnF2) as both a monographed

anticaries agent and a monographed antigingivitis agent, along with sodium hexametaphosphate and zinc lactate. Twenty-five healthy

subjects meeting all study criteria were included into each of the double-blind studies. Product assignment was randomized and a

crossover design was implemented. Informed consent was obtained from all subjects prior to commencement of each of the studies.

The studies followed published MGMPI procedures, which require subjects to receive a dental scaling/prophylaxis followed by a

one-week washout period prior to use of test products. A baseline MGMPI score was calculated following use of the test products

in the dental clinic. Subjects refrained from all oral hygiene for 24 hours following use of each test product, and returned to the

clinic for a 24-hour MGMPI score. Following a washout period, subjects repeated the procedure with the other test product as per the

crossover design. The differences (delta) between baseline plaque scores and 24-hour plaque scores were independently calculated

for each study, and the delta values were compared for the two test products in each of the studies.

• Results: In all three clinical trials, Colgate Total significantly reduced plaque regrowth over a 24-hour time period (p ≤ 0.05)

compared to Crest Pro-Health. Existing differences were determined via a paired t-test, which confirmed that Colgate Total was

statistically significantly different from Crest Pro-Health.

• Conclusion: These in vivo data support the antiplaque benefit of the 0.3% triclosan/2.0% PVM/MA copolymer/0.243% sodium

fluoride dentifrice. Additionally, the results support that Colgate Total provides superior efficacy in inhibiting the formation of dental

plaque compared to Crest Pro-Health.


101

IntroductionPlaque removal by way of a daily home care regimen has

long been understood by the dental professional and consumers

to be an important element of oral health. The use of a dentifrice

in one form or another dates back to ancient Greek and Roman

civilizations, commencing with powder formulations containing

a myriad of interesting ingredients.1 Dental plaque contributes to

several concerns, both cosmetic and pathologic in nature. For in-

stance, dental plaque contributes to caries, periodontal disease,

and halitosis. Emerging evidence strongly suggests the oral

inflammation caused by the bacteria living in the dental plaque

may contribute to various systemic diseases, including, but not

limited to diabetes, cardiovascular disease, low birth weight,

preterm babies, and osteoporosis.2

Worldwide, many techniques and products designed to achieve

improved oral health exist; toothbrushes, rinses, floss, and den-

tifrices, to name a few, are available for consumers to purchase.

Numerous clinical studies have been conducted examining the

efficacy of examples of each of the above-mentioned products

with variable results. Many limitations exist in plaque removal

with a conventional brush and paste, including but not limited to

manual dexterity, dental anatomy, and personal habits.3

Adjunctive products and procedures, as well as clinically proven

chemotherapeutic products, have been suggested to im prove the

outcome, including improving the design of the toothbrush for im-

proved mechanical removal, and improving the dentifrice to de-

liver an agent to retard plaque regrowth. One example was the de-

velopment of the only FDA-approved and ADA- accepted dentifrice

with anticaries, anti plaque, and anti gingivitis benefits, containing

0.3% triclosan/2.0% PVM/MA copolymer/0.243% sodium fluoride

in a silica base (Colgate® Total®, Colgate-Palmolive Co., New York,

NY, USA). Numerous clinical studies have been conducted world-

wide documenting the efficacy of this product for anticaries, anti -

plaque, and anti gingivitis effects.4-6 Among four published caries

clinical studies, a 36-month controlled, double-blind study found

Colgate Total (CT) to significantly reduce the formation of cav-

ities compared to a control dentifrice containing fluoride alone.4

In several six- or seven-month double-blind studies, CT sig -

nificantly reduced plaque accumulation and gingivitis when used

twice daily, compared to a dentifrice containing sodium fluoride.6


both the stannous fluoride and the sodium hexametaphosphate,

and to mitigate other downsides of stannous fluoride, such as

tooth staining.14 When tested against a placebo, both dentifrice

and mouthrinse formulations were found to reduce both plaque

and gingivitis. A 12-week monadic, unblinded clinical study

examined subjects with average baseline Gingival Index (GI)

scores of 0.48 (on the Löe-Silness GI scale of 0–3). Following

a twice-daily regimen with the CPH product, the average post-

treatment GI score fell 0.09 points to 0.39.15

The aim of this clinical research was to test, in three separate

clinical studies, the ability of Colgate Total and Crest Pro-Health

to prevent plaque formation, in vivo, over 24 hours.

Materials and MethodsThree products were used in the clinical studies: Colgate Total

with 0.3% triclosan/2.0% PVM/MA copolymer/0.243% sodium

fluoride in a silica base; Crest Pro-Health with 0.454% stannous

fluoride in a silica base with sodium hexametaphosphate and zinc

lactate; and Colgate® Great Regular Flavor (Colgate-Palmolive

Company, New York, NY, USA) as a wash out product with 0.76%

sodium monofluorophosphate. All toothbrushes were adult soft

toothbrushes manufactured by the Colgate-Palmolive Company.

Three clinical studies were conducted utilizing the published

Modified Gingival Margin Plaque Index (MGMPI). Each of the

three studies used the same 25 healthy human subjects meeting

the following criteria. All subjects ranged in age from 18–65, and

were required to have a minimum of 15 healthy (uncrowned)

teeth, excluding third molars. All subjects needed to provide

written informed consent, and be willing to discontinue oral hy-

giene for 24 hours. Subjects with any known allergy to personal

care or consumer products with ingredients relevant in any way

to the test products (including tin) were excluded. Additional ex-

clusion criteria included any conditions requiring pre-medication

for dental visits, advanced periodontal disease, extensive un-

treated dental caries, and diseases of the hard or soft palate.

Subjects wearing orthodontic appliances, or presenting with

abnormal salivary flow, or taking drugs affecting salivary flow

were also excluded. The use of antibiotics for one month prior

to or during the study was also an exclusion criterion. Subjects

taking over-the-counter medications (other than basic analgesics)

and subjects participating in other clinical studies were excluded.

Subjects currently pregnant or breastfeeding, as well as subjects

suffering from immunocompromised states were excluded.

All three studies were conducted with the same clinical proce -

dure. Subjects willing to sign the informed consent and meeting

all inclusion and exclusion criteria were treated in the dental

clinic. Dental scaling and prophylaxis were performed to com-

pletely remove dental plaque and dental calculus. Subjects were

given washout products, Colgate Great Regular Flavor toothpaste

and a Colgate soft manual toothbrush, with the instructions to use

only these products and to brush twice daily for the washout pe-

riod. Subjects returned to the dental clinic approximately one

week after the commencement of the washout period. Study

treatments were assigned via a randomized, incomplete block

design using an alternating pattern starting with the first panel-

ist enrolled. In the clinic, they brushed for one minute with a

full ribbon of Colgate Great Regular Flavor. This brushing was

Several short-term, 24-hour, and four-day clinical studies have

consistently found formulations of 0.3% triclosan/2.0%

PVM/MA copolymer/0.243% sodium fluoride in a silica base to

prevent the development of dental plaque more efficaciously

than a dentifrice containing sodium fluoride or sodium mono-

fluorophosphate (MFP) alone.7 The 24-hour studies employed

the Modified Gingival Margin Plaque Index (MGMPI), a well-

published methodology to examine the growth of dental plaque

along the gingival margin over a 24-hour period following the

use of an oral care product.8 The four-day studies utilized the

Quigley Hein Plaque Index, with the published four-day plaque

regrowth regimen.9

The unique nature of CT is found in the combination of the

active ingredient, triclosan, in conjunction with the copolymer.

Triclosan is a longstanding ingredient in consumer products,

used safely and effectively for over 30 years. Triclosan has a rare

and useful dual function. It serves as an antibacterial agent, as

well as an anti-inflammatory agent.5 The copolymer ensures the

delivery and retention of the triclosan, allowing for bioavail-

ability in the oral cavity for 12 hours. This 12-hour bioavailability

is instrumental for delivering the antiplaque and antigingivitis ef-

ficacy of CT. A plaque viability study, published by Amornchat,

et al. in Thailand, documented the retention of triclosan in den-

tal plaque and its sustained antibacterial effects 12 hours after a

single brushing with CT, confirming the long-lasting antiplaque-

bacteria benefit.10

Inflammation is the natural physiologic process to combat

infection. Acute inflammation, if kept under control, aids in pro-

moting initial tissue repair. Chronic inflammation, however, may

lead to tissue destruction. Gingivitis, inflammation of the gingi-

val tissue, if left untreated may become chronic and progress into

the more destructive stages of periodontitis.11 CT has been shown

to be effective in treating gingivitis, the result of both the anti -

bacterial effect and the anti-inflammatory effect of the triclosan

found in the dentifrice. In laboratory studies, Modeer, et al.

demonstrated that as IL-1� was increased from 50 pg/ml to 200

pg/ml, the presence of triclosan at 1 μg/ml prevented a signifi-

cant increase of prostaglandin E2

(PGE2) production.12

Several short- and long-term, double-blind, randomized clin-

ical trials, evaluating both antiplaque and antigingivitis efficacy

of CT, were conducted. The duration of the studies ranged from

one week to six months. CT was tested versus a placebo denti-

frice. Plaque was scored using the widely accepted modified

Quigley-Hein Plaque Index.13 The gingivitis scoring method

used to assess gingivitis was the Löe-Silness Gingival Scoring

Index.9 CT was found to consistently deliver a superior anti -

plaque and antigingivitis benefit over the placebo dentifrice.

A stannous fluoride-based dentifrice, containing 0.454% SnF2

as both a monographed anticaries and antigingivitis agent, also

containing sodium hexametaphosphate and zinc lactate, is mar-

keted under the commercial name of Crest® Pro-Health® (CPH,

Procter & Gamble Co., Cincinnati, OH, USA). Historically,

use of stannous fluoride in dentifrices has been limited, in part

due to its instability in aqueous formulae. Further, use of so -

dium hexametaphosphate has also limited long-term stability in

aqueous vehicles. For this reason, Crest® Pro-Health® has been

formulated in a low water silica-based dentifrice to stabilize


followed by a one-minute brushing, again with a full ribbon of

the assigned test product. All products were blinded to both the

subject and the examiner by way of an over-wrap. Following

these brushing procedures, subjects were free to rinse with wa-

ter and were then instructed to rinse with approximately 10 ml

of a red commercial disclosing solution for 30 seconds. The

dental examiner obtained the baseline MGMPI plaque score.

Subjects were then instructed to refrain from all oral hygiene for

24 hours. Twenty-four hours later, the subjects returned to the

dental clinic, rinsed with the disclosing solution, and the dental

examiner obtained the final MGMPI plaque score.

The above procedure was repeated in accordance with the

crossover design, so that both products could be tested by each

individual in each of the clinical studies. One subject in study

#1 did not complete the study due to antibiotic use at the start of

the study. The need for the antibiotics was determined to be un-

related to the clinical study.

For each subject and each product, the baseline MGMPI

plaque score was subtracted from the final MGMPI plaque score,

rendering a delta value for the change in plaque score according

to a previously published formula.8 This delta reflects the amount

of plaque that developed over the 24-hour period. Measure-

ments were obtained using the patented Xu-Barnes probe.8

Statistical AnalysisChange in the MGMPI plaque score in a 24-hour post- treatment

(no brushing) period was calculated for each subject for each

treatment cell. A paired t-test, using the subject and treatment

as factors, was used to detect if significant differences be-

tween products exist. A difference between treatments is con-

sidered to be significant if a 95% confidence level (p < 0.05) is

achieved.

ResultsAll three studies provided results demonstrating CT provided

a significant (p ≤ 0.05) antiplaque effect compared to CPH when

using the products in a randomized manner (Figure 1 and Table I).

DiscussionMany oral care products exist in the marketplace today. Con-

sumers increasingly demonstrate their understanding of the value

of high quality oral care products, and the importance of good

oral hygiene. Various efficacy claims, such as antiplaque, antigingi -

vitis, whitening, and antitartar, are often made. In an evidence-

based domain, such claims need to be documented. Whenever

possible, the most rigorous level of testing, the double-blind

randomized clinical trial, is desirable.

Many plaque assessment methods have been published, and

have been used to assess product efficacy with great success. Two

commonly used methods for short-term studies are the Quigley-

Hein Plaque Index (QHPI), used in the four-day plaque regrowth

model,13 and the Modified Gingival Margin Plaque Index

(MGMPI), used in the 24-hour plaque regrowth model.8 The two

methods have been published extensively, and a 2005 paper

compared the four-day methodology with the MGMPI.16 Fol-

lowing the review of several clinical studies, the paper found both

methods predicted the long-term (six-month) antiplaque efficacy

of commercial products in a similar fashion. A 2008 paper re-

viewed 29 clinical studies utilizing the MGMPI methodology. All

studies tested two commercial products, the therapeutic dentifrice

containing 0.3% triclosan/2.0% PVM/MA copolymer/0.243%

sodium fluoride in a silica base versus a regular fluoride denti-

frice. Twenty-four of the 28 studies predicted the superiority of

the therapeutic dentifrice over the regular fluoride dentifrice. The

four studies, failing to show superiority, were determined to be

underpowered when reviewing the sample size of each. 17

The three clinical studies presented in this paper were suffi-

ciently powered to be able to detect differences between two

products, should those differences exist. Additionally, the design

of a double-blind, randomized clinical trial satisfies the rigorous

expectations for evidence-based documentation. The same sub-

jects and the same examiner were recruited for all three studies,

reducing unnecessary variability.

To summarize the findings, in all three trials CT significantly

reduced plaque regrowth over 24 hours compared to CPH.

Exist ing differences were determined via a two-way ANOVA.

The t-test confirmed that CT was statistically significantly dif-

ferent from CPH.

ConclusionColgate Total inhibited the formation of dental plaque over 24

hours versus Crest Pro-Health in a statistically significant fash-

ion. These in vivo data provide compelling results to support the

antiplaque benefit of the 0.3% triclosan/2.0% PVM/MA copolymer/

0.243% sodium fluoride dentifrice. Additionally, the results

Table I

The Mean (± SD) Difference in MGMPI Scores Between

Baseline and 24 Hours After Using Either CT or CPH and the

Statistical Comparison Between Products

CT CPH

Study # 1 14.14 ± 8.02* 22.05 ± 12.42

Study # 2 12.95 ± 7.18* 25.35 ± 10.08

Study # 3 9.65 ± 8.30* 27.09 ± 11.95

*Test products are statistically different (p < 0.05 at 95% confidence level).

Figure 1. The average mean MGMPI scores depicted for three clinical studies

demonstrating a single use of CT resulted in significantly less dental plaque for-

mation as compared to a single use of CPH post-brushing over a 24-hour time

period.


support that Colgate Total provides superior efficacy in inhibiting

the formation of dental plaque compared to Crest Pro-Health.

Acknowledgment: This study was supported by the Colgate- Palmolive Company.


contact Dr. Virginia Barnes—[email protected].

References1. Fischman S. The history of oral hygiene products: How far have we come

in 6000 years? Periodontology 2000 1997;15:7-14.

2. Scannapieco FA. Periodontal inflammation: From gingivitis to systemic

disease? Compend Contin Educ Dent 2004;25(7 Suppl 1):16-25.

3. Myoken Y, Yamane Y, Myoken Y, Nishida T. Plaque removal with an ex-

perimental chewable toothbrush and a control manual toothbrush in a care-

dependent elderly population: A pilot study. J Clin Dent 2005;16:83-86.

4. Mann J, Vered Y, Babayof I, Sintes J, Petrone ME, Volpe AR, Stewart B,

DeVizio W, McCool JJ, Proskin HM. The comparative anticaries efficacy

of a dentifrice containing 0.3% triclosan and 2.0% copolymer in a 0.243%

sodium fluoride/silica base and a dentifrice containing 0.243% sodium fluoride/

silica base: a two-year coronal caries clinical trial on adults in Israel. J Clin

Dent 2001;12:71-76.

5. Panagakos FS, Volpe AR, Petrone ME, DeVizio W, Davies RM. Advanced

oral antibacterial/anti-inflammatory technology: A comprehensive review of

the clinical benefits of a triclosan/copolymer/fluoride dentifrice. J Clin Dent

2005;16:S1-S19.

6. DeVizio W. The efficacy of a new dentifrice with caries, plaque, gingivitis,

calculus, tooth whitening, and malodor benefits. J Clin Dent 2008;19:

79-80.

7. Barnes VM, Vandeven M, Richter R, Xu T. The modified gingival margin

plaque index: A predictable clinical method. J Clin Dent 2008;19:131-133.

8. Xu T, Barnes VM. The development of a new dental probe and a new

plaque index. J Clin Dent 2003;14:93-97.

9. Löe H, Silness J. Periodontal disease in pregnancy. Prevalence and sever-

ity. Acta Odontol Scand 1963;21:533-551.

10. Amornchat C, Kraivaphan P, Triratana T. Investigation of a triclosan/copoly-

mer dentifrice on plaque viability and triclosan retention in dental plaque in

a Thai population. Mahidol Dent J 2004;24:103-111.

11. Mariotti A. A primer on inflammation. Compend Contin Educ Dent 2004;

25:7-15.

12. Modeer T, Bengtsson A, Rolla G: Triclosan reduces prostaglandin biosyn-

thesis in human gingival fibroblasts challenged with interleukin-1 in vitro.

J Clin Periodontol 1996;23:927-933.

13. Quigley GA, Hein JW. Comparative cleansing efficacy of manual and power

brushing. J Am Dent Assoc 1962;65:26-29.

14. Baig A, He T. A novel dentifrice technology for advanced oral health pro-

tection: A review of technical and clinical data. Compend Contin Educ

Dent 2005;26(9 Suppl 1):4-11.

15. Archila L, He T, Winston JL, Biesbrock AR, McClanahan SF, Bartizek RD.

Antigingivitis efficacy of a stabilized stannous fluoride/sodium hexam-

etaphosphate dentifrice in subjects previously nonresponsive to a tri-

closan/copolymer dentifrice. Compend Contin Educ Dent 2005;26(9 Suppl

1):12-18.

16. Xu T, Barnes VM. Comparison of two clinical methods for evaluating the

anti-plaque efficacy of a dentifrice. J Clin Dent 2005;15:97-102.

17. Barnes VM, Vandeven M, Richter R, Xu T. The modified gingival margin

plaque index: A predictable clinical method. J Clin Dent 2008;19:131-133.

A Clinical Investigation of the Efficacy of Three Commercially AvailableDentifrices for Controlling Established Gingivitis and Supragingival Plaque

Surendra Singh, DDS

UMDNJ, New Jersey Dental School

Newark, NJ, USA

and

Oral Health Clinical Services

Piscataway, NJ, USA

Patricia Chaknis, BS William DeVizio, DMD

Margaret Petrone, JD Fotinos S. Panagakos, DMD, PhD


Piscataway, NJ, USA

Howard M. Proskin, PhD

Howard M. Proskin & Associates, Inc.

Rochester, NY, USA

Abstract• Objective: To assess the efficacy of a dentifrice containing 0.3% triclosan/2.0% PVM/MA copolymer/0.243% sodium fluoride for

controlling established gingivitis and supragingival plaque relative to that of a dentifrice containing 0.454% stannous fluoride, sodium

hexametaphosphate, and zinc lactate, and a dentifrice containing 0.243% sodium fluoride as a negative control.

• Methods: Following a baseline examination for gingivitis and supragingival plaque, qualifying adult male and female subjects from

the Piscataway, NJ, USA area were randomized into three dentifrice groups. Subjects were instructed to brush their teeth twice daily

(morning and evening) for one minute with their assigned dentifrice and a soft-bristled toothbrush. Examinations for gingivitis and

supragingival plaque were repeated after six weeks of product use.

• Results: One-hundred and seventy-one (171) subjects complied with the protocol and completed the study. Relative to the group

using the dentifrice with 0.243% sodium fluoride alone, the 0.3% triclosan/2.0% PVM/MA copolymer/0.243% sodium fluoride group

exhibited statistically significant reductions in gingival index and supragingival plaque index scores of 25.3% and 33.0%, respec-

tively, after six weeks of product use. Similarly, relative to the group using the 0.243% sodium fluoride dentifrice, the 0.454%

stannous fluoride, sodium hexametaphosphate, and zinc lactate dentifrice group exhibited statistically significant reductions in gin-

gival index and plaque index scores of 8.1% and 14.1% after six weeks of product use. Further, relative to the 0.454% stannous

fluoride, sodium hexametaphosphate, and zinc lactate dentifrice group, the 0.3% triclosan/2.0% PVM/MA copolymer/0.243% sodium

fluoride dentifrice group exhibited statistically significant reductions in gingival index and plaque index scores of 18.7% and 22%,

respectively

• Conclusion: The overall results of this double-blind clinical study support the conclusion that a dentifrice containing 0.3%

triclosan/2.0% PVM/MA copolymer/0.243% sodium fluoride is efficacious for the control of established gingivitis and supragin-

gival plaque as compared to a regular fluoride dentifrice, and that it provides a greater level of efficacy for the control of gingivitis

and supragingival plaque than does a dentifrice containing 0.454% stannous fluoride, sodium hexametaphosphate, and zinc lactate.


105

IntroductionIt is well accepted that bacterial plaque (biofilm) is the fore-

runner to gingivitis,1 and that gingivitis is widespread in the

general population.1-3 If left untreated, gingivitis can lead to pe-

riodontitis, a more serious form of periodontal disease. Perio -

dontal disease, along with dental caries, is a common oral con-

dition in adults today.4 Based upon survey data, it has been

suggested that over 75% of today’s adult population is affected

by the occurrence of gingivitis.5 The use of fluoridated tooth-

pastes and mouthrinses, and water fluoridation have resulted in

a decline in dental caries. However, gingivitis and periodontitis

have not followed a similar pattern of decline. Over 750 species

of bacteria can be found in the oral cavity, and specific groups

of bacteria among these are the precursors to periodontal disease,

including gingivitis and periodontitis.6,7

Even with effective tooth cleaning, bacteria colonize the tooth

surface, most notably around the gingival margin and interden-

tal spaces.8 The developing biofilm (plaque) releases a variety of

biologically active products that diffuse into the gingival ep-

ithelium to initiate the host response that eventually results in gin-

givitis. Left untreated, periodontal pockets may form, bone could

resorb, and the tooth might be lost.

Having a disease-free oral cavity is now more important than

ever. Over the last ten years, epidemiologic and clinical studies


phate has been reported in the literature to reduce calculus for-

mation, and has also been demonstrated to reduce staining.21

The objective of this six-week clinical study was to compare,

head-to-head, the antiplaque and antigingivitis efficacy of a denti -

frice containing 0.3% triclosan/2.0% PVM/MA copolymer/0.243%

sodium fluoride to a dentifrice containing 0.454% stannous

fluoride, sodium hexametaphosphate, and zinc lactate. A denti-

frice containing 0.243% sodium fluoride alone was included as

a negative control. Gingivitis and plaque evaluations were con-

ducted at baseline and after six weeks of product use.

Materials and MethodsThis clinical investigation, including the consent form, was re-

viewed by an Institutional Review Board in accordance with Ti-

tle 21 of the Code of Federal Regulations, Parts 50 and 56. This

study employed a double-blind, randomized, three-treatment,

parallel-group design. Adult male and female subjects from the

Piscataway, NJ, USA area were enrolled into the study based

upon the following criteria:

• Subjects had to be between 18 and 70 years of age, in good

general health, and have signed an Informed Consent.

• Subjects were required to be available for the six-week du-

ration of the study.

• Subjects had to possess at least 20 uncrowned permanent

natural teeth (excluding third molars).

• Subjects were required to present at baseline with a mean

gingival index score of at least 1.0 as determined by the use

of the Löe-Silness Gingival Index,22,23 and a mean plaque in-

dex score of at least 1.5 as determined by the use of the

Turesky modification of the Quigley-Hein Plaque Index.24,25

Subjects were excluded from study participation if they:

• had partial removable dentures, orthodontic bands, or ad-

vanced periodontal disease (purulent exudate, tooth mobil-

ity, and/or extensive loss of periodontal attachment or alve-

olar bone).

• had tumor(s) of the soft or hard oral tissues or five or more

carious lesions requiring immediate restorative treatment.

• had a history of allergies to personal care/consumer products

or their ingredients, or they could not refrain from eating or

drinking due to medical conditions for periods of up to four

hours.

• were pregnant or breast feeding women, or individuals who

participated in any other clinical study or panel test within

the last month of the start of the study.

• used antibiotics at any time during the one-month period

prior to entering the study, were taking any prescription

medication that might interfere with the study outcome, or

received a dental prophylaxis during the two weeks prior to

the study baseline examination.

Prospective subjects reported to the clinical facility having re-

frained from any oral hygiene procedures for 12 hours, and eat-

ing, drinking, and smoking for four hours prior to the visit. Sub-

jects signed an Informed Consent form, and were screened by the

dental examiner with respect to the inclusion/exclusion criteria.

Subjects who met the inclusion/exclusion criteria received a

baseline gingivitis and supragingival plaque examination and an

oral soft and hard tissue assessment.

have been conducted to understand the relationship between

oral and systemic health. It is now believed that oral inflam -

mation associated with periodontitis may contribute to systemic

inflammation which has been associated with systemic dis-

eases, most notably coronary heart disease, peripheral arterial

disease, ischemic stroke, and diabetes.9 Therefore, it is vitally

important to control the formation of plaque and gingival

inflammation.

The most common method of supragingival plaque control is

by tooth brushing, which is the mechanical removal of plaque.10

The American Dental Association recommends brushing twice

a day and flossing once a day as a regimen for good oral hy-

giene.11 The problem is that most people do not brush that often

or brush long enough to achieve sufficient plaque removal, or do

not brush properly in order to receive optimum results.

Dental professionals worldwide agree that self-performed

plaque control is not adequate to achieve gingival health.12 In

fact, it has been reported in one study that 94% of subjects said

they brushed and flossed every day, and yet all subjects had vis-

ible plaque on more than 90% of tooth surfaces.13

In the early 1990s, a dentifrice was introduced into the mar-

ketplace which incorporated a chemotherapeutic agent with anti -

plaque activity (0.3% triclosan) and a copolymer of polyvinyl-

methyl ether and maleic acid (2.0% PVM/MA copolymer) into

a 0.243% sodium fluoride dentifrice, which was clinically proven

to reduce plaque and gingivitis in an adult population (Colgate®

Total® Toothpaste, Colgate-Palmolive Co., New York, NY,

USA). Triclosan is a bisphenolic antibacterial agent which has

low toxicity and a broad spectrum of activity, being effective

against both gram positive and gram negative bacteria.14 Colgate

Total Toothpaste also contains the copolymer PVM/MA which

when combined with triclosan, ensures delivery and retention of

the triclosan on hard and soft tissues.15,16 Effective levels of tri-

closan are retained in the oral cavity 12 hours after brushing the

teeth, allowing prolonged control of oral bacteria that cause

plaque, gingivitis, tartar, and bad breath. It has been shown in

long-term clinical studies to provide anticaries benefits, and has

been clinically shown to reduce the recurrence of periodontal

disease.15,16

The combination of 0.3% triclosan/2.0% PVM/MA copolymer/

0.243% sodium fluoride has been clinically proven, in over

seventy clinical studies, to provide oral health benefits.17 The ef-

ficacy, mode of action, and safety of a triclosan/PVM/MA

copolymer/sodium fluoride toothpaste has been thoroughly re-

searched in over 200 articles in the scientific literature.4 Colgate

Total Toothpaste is the only toothpaste approved by the US Food

and Drug Administration for the prevention of plaque and gin-

givitis, and is accepted by the American Dental Association for

the prevention of plaque and gingivitis.18

More recently, a dentifrice was introduced into the market-

place claiming antigingivitis efficacy. The dentifrice contains

0.454% stannous fluoride, sodium hexametaphosphate, and zinc

lactate. Stannous fluoride, like sodium fluoride, is an active in-

gredient found in dentifrices to reduce caries. There have been

reports in the literature which show that stannous fluoride is ef-

fective in reducing gingivitis, but it has also been shown to

cause surface staining of the teeth.19,20 Sodium hexametaphos-


Qualifying subjects were randomized into one of three treat-

ment groups which were balanced for baseline gingivitis and

supragingival plaque scores. The three dentifrices tested in this

study were as follows: 1) a commercially available dentifrice

containing 0.3% triclosan/2.0% PVM/MA copolymer/0.243%

sodium fluoride (Colgate Total Toothpaste); 2) a commercially

available dentifrice containing 0.454% stannous fluoride, sodium

hexametaphosphate, and zinc lactate (Crest® Pro-Health® Tooth-

paste, Procter & Gamble Company, Cincinnati, OH, USA); and

3) a commercially available dentifrice containing 0.243% sodium

fluoride (Crest® Cavity Protection Toothpaste, Procter & Gamble

Company, Cincinnati, OH, USA).

Following treatment assignment, subjects were provided with

a soft-bristled toothbrush and their assigned dentifrice. All den-

tifrices were over-wrapped in their original package to maintain

the double-blind study design. Subjects were instructed to brush

their teeth with their assigned dentifrice and toothbrush twice

daily (morning and evening) for one minute, and to use only the

dentifrice and toothbrush provided. There were no restrictions re-

garding diet or smoking during the course of the study, although

subjects were instructed to refrain from any oral hygiene proce-

dures for twelve hours, and eating, drinking, and smoking for

four hours prior to their six-week study examinations. Subjects

returned to the clinical facility for gingivitis and supragingival

plaque examinations after six weeks of product use. Additionally,

at each examination subjects received an evaluation of their oral

soft tissue by the examining dentist and were questioned for the

occurrence of any adverse events.

Clinical Scoring ProceduresLöe-Silness Gingival Index. Gingivitis was scored according

to the Löe-Silness Gingival Index. Each tooth was divided into

six surfaces, three facial and three lingual, as follows: 1) mesio-

facial; 2) mid-facial; 3) disto-facial; 4) mesio-lingual; 5) mid-

lingual; and 6) disto-lingual. Third molars and those teeth with

cervical restorations or prosthetic crowns were excluded from the

scoring procedure. The gingiva adjacent to each tooth surface

was scored as follows:

0 = Absence of inflammation.

1 = Mild inflammation—slight change in color and little change

in texture.

2 = Moderate inflammation—moderate glazing, redness, edema,

and hypertrophy. Bleeding on probing.

3 = Severe inflammation—marked redness and hypertrophy.

Tendency for spontaneous bleeding.

Subject-wise scores were determined by averaging the values

obtained over all scoreable surfaces in the mouth.

Quigley-Hein Plaque Index. Plaque was scored according to

the Turesky modification of the Quigley-Hein Plaque Index.

Each tooth was divided into six surfaces, three facial and three

lingual, as follows: 1) mesio-facial; 2) mid-facial; 3) disto-facial;

4) mesio-lingual; 5) mid-lingual; and 6) disto-lingual. Third mo-

lars and those teeth with cervical restorations or prosthetic

crowns were excluded from the scoring procedure. Plaque was

disclosed and scored on each tooth surface according to the fol-

lowing criteria:

0 = No plaque.

1 = Separate flecks of plaque at the cervical margin.

2 = A thin, continuous band of plaque (up to 1 mm) at the cer-

vical margin.

3 = A band of plaque wider than 1 mm, but covering less

than 1/3 of the side of the crown of the tooth.

4 = Plaque covering at least 1/3, but less than 2/3 of the side

of the crown of the tooth.

5 = Plaque covering 2/3 or more of the side of the crown of

the tooth.



Oral Soft and Hard Tissue Assessment. The dental exam-

iner visually examined the oral cavity and peri-oral area using a

dental light and dental mirror prior to each plaque and gingivi-

tis examination. This examination included an evaluation of the

soft and hard palate, gingival mucosa, buccal mucosa, mucogin-

gival fold areas, tongue, sublingual and submandibular areas,

salivary glands, and the tonsilar and pharyngeal areas.

Adverse Events. Adverse events were determined by verbal

indications from the subjects or by visual examination of the den-

tal examiner.

Statistical MethodsStatistical analyses were performed separately for the gingi-

val index and plaque index scores. Comparisons of the treatment

groups with respect to baseline gingival index and plaque index

scores, as well as for age, were performed using analyses of

variance (ANOVA). Within-treatment comparisons of the gin-

gival index and plaque index scores obtained at the six-week ex-

aminations versus baseline were performed using paired t-tests.

Comparisons between treatment groups with respect to gender

were performed using chi-square tests. Comparisons of the

treatment groups with respect to baseline-adjusted gingival index

and plaque index scores at the six-week examinations were

performed using analyses of covariance (ANCOVA). Post-

ANCOVA pair-wise comparisons of the gingival and plaque

indices scores were performed using the Tukey test for multiple

comparisons. All statistical tests of hypothesis were two-sided

and employed a level of significance of � = 0.05.

ResultsOne-hundred seventy-one (171) subjects complied with the

protocol and completed the six-week clinical study. A summary

of the gender and age of the population who completed the study

is presented in Table I. The treatment groups did not differ sig-

nificantly with respect to either of these characteristics. Through-

out the study, no adverse effects on the oral hard or soft tissues

were observed by the examiner or reported by the subjects when

questioned.

Baseline DataLöe-Silness Gingival Index and Quigley-Hein Plaque Index.

Table II presents a summary of the gingival and plaque index

scores measured at baseline for subjects who completed the

study. The mean baseline gingival index scores were 1.13 for

the 0.3% triclosan/2.0% PVM/MA copolymer/0.243% sodium


fluoride dentifrice group, 1.09 for the 0.454% stannous fluoride,

sodium hexametaphosphate, and zinc lactate dentifrice group,

and 1.11 for the 0.243% sodium fluoride dentifrice group. The

mean baseline plaque index scores were 2.34 for the 0.3% tri-

closan/2.0% PVM/MA copolymer/0.243% sodium fluoride den-

tifrice group, 2.27 for the 0.454% stannous fluoride, sodium

hexametaphosphate, and zinc lactate dentifrice group, and 2.22

for the 0.243% sodium fluoride dentifrice group. No statisti-

cally significant differences were indicated among the denti-

frice groups with respect to gingival or plaque index scores at

baseline.

Six-Week DataLöe-Silness Gingival Index. Table III presents a summary of

the gingival index scores measured at the six-week examinations.

The mean six-week gingival index scores were 0.74 for the 0.3%

triclosan/2.0% PVM/MA copolymer/0.243% sodium fluoride

dentifrice group, 0.91 for the 0.454% stannous fluoride, sodium


for the 0.243% sodium fluoride dentifrice group.

Comparisons vs. Baseline. The mean percent reductions

from baseline were 34.5% for the 0.3% triclosan/2.0% PVM/MA

copolymer/0.243% sodium fluoride dentifrice group, 16.5% for

the 0.454% stannous fluoride, sodium hexametaphosphate, and

zinc lactate dentifrice group, and 10.8% for the 0.243% sodium

fluoride dentifrice group. All reductions were statistically sig-

nificant at the 95% confidence level.

Comparisons Among Dentifrice Groups. Relative to the


lactate dentifrice group, the 0.3% triclosan/2.0% PVM/MA

copolymer/0.243% sodium fluoride dentifrice group exhibited a

statistically significant 18.7% reduction in gingival index scores

Table I

Summary of Gender and Age for Subjects

Who Completed the Six-Week Clinical Study

Number of Subjects Age

Dentifrice Male Female Total Mean Range

0.3% triclosan/

2.0% PVM/MA copolymer/

0.243% sodium fluoride1

21 36 57 40.4 19–70

0.454% stannous fluoride/

sodium hexametaphosphate/

zinc lactate2

27 31 58 41.4 19–70

0.243% sodium fluoride3 20 36 56 39.6 18–76

1Colgate Total Toothpaste.2Crest Pro-Health Toothpaste.3Crest Cavity Protection Toothpaste.

Table II

Summary of the Baseline Löe-Silness Gingival Index Scores

and Quigley-Hein Plaque Index Scores for Subjects


Baseline

Summary

Parameter Treatment n (Mean ± SD)4

0.3% triclosan/2.0% PVM/MA

copolymer/0.243% sodium fluoride1 57 1.13 ± 0.09

0.454% stannous fluorideGingivitis


zinc lactate2 58 1.09 ± 0.09

0.243% sodium fluoride3 56 1.11 ± 0.12



Plaque0.454% stannous fluoride/


zinc lactate2 58 2.27 ± 0.41

0.243% sodium fluoride3 56 2.22 ± 0.43

1Colgate Total Toothpaste.2Crest Pro-Health Toothpaste.3Crest Cavity Protection Toothpaste.4No statistically significant difference was indicated among the three dentifrice

groups at baseline

Table III

Summary of the Six-Week Gingival Index Scores for Subjects Who Completed the Six-Week Clinical Study

Between-Treatment ComparisonsWithin-Treatment

Analysis vs. Crest Pro-Health vs. Negative Control

Six-Week Summary Percent Percent Percent

Treatment n (Mean ± SD) Reduction4 Sig.5 Difference6 Sig.7 Difference8 Sig.7

0.3% triclosan/2.0% PVM/MA copolymer/

0.243% sodium fluoride1 57 0.74 ± 0.11 34.5% p < 0.05 18.7% p < 0.05 25.3% p < 0.05

0.454% stannous fluoride/sodium

hexametaphosphate/zinc lactate 2 58 0.91 ± 0.13 16.5% p < 0.05 — — 8.1% p < 0.05

0.243% sodium fluoride3 56 0.99 ± 0.15 10.8% p < 0.05 — — — —

1Colgate Total Toothpaste.2Crest Pro-Health Toothpaste.3Crest Cavity Protection Toothpaste.4Percent reduction exhibited by the six-week mean relative to the baseline mean. A positive value indicates a lower gingivitis score at the six-week examination.5Significance of paired t-test comparing the baseline and six-week gingival index scores.6Difference between six-week means expressed as a percentage of the six-week mean for Crest Pro-Health Toothpaste. A positive value indicates a lower gingivitis score

for Colgate Total Toothpaste than for Crest Pro-Health Toothpaste.7Significance of post-ANCOVA comparison of baseline-adjusted means.8Difference between six-week means expressed as a percentage of the six-week mean for Crest Cavity Protection Toothpaste. The higher the percent difference the greater

the gingivitis efficacy for the dentifrice.


after six weeks of product use (p ≤ 0.05). Relative to the 0.243%

sodium fluoride dentifrice group, the 0.3% triclosan/2.0%

PVM/MA copolymer/0.243% sodium fluoride dentifrice group

exhibited a statistically significant reduction in gingival index

scores of 25.3%, while the 0.454% stannous fluoride with sodium

hexametaphosphate and zinc lactate dentifrice group exhibited

a statistically significant 8.1% lower gingival index score, both

after six weeks of product use (p ≤ 0.05).

Quigley-Hein Plaque Index. Table IV presents a summary of

the plaque index scores measured at the six-week examinations.

The mean six-week plaque index scores were 1.38 for the 0.3%


dentifrice group, 1.77 for the 0.454% stannous fluoride, sodium


for the 0.243% sodium fluoride dentifrice group.

Comparisons vs. Baseline. The mean percent reductions

from baseline were 41% for the 0.3% triclosan/2.0% PVM/MA

copolymer/0.243% sodium fluoride dentifrice group, 22% for the


lactate dentifrice group, and 7.2% for the 0.243% sodium fluo-

ride dentifrice group. All reductions were statistically significant

at the 95% confidence level.



lactate dentifrice group, the 0.3% triclosan/2.0% PVM/MA

copolymer/0.243% sodium fluoride dentifrice group exhibited a

statistically significant 22% reduction in plaque index scores


Relative to the 0.243% sodium fluoride dentifrice group, the

0.3% triclosan/2.0% PVM/MA copolymer/0.243% sodium

fluoride dentifrice group exhibited a statistically significant re-

duction in plaque index scores of 33%, while the 0.454%

stannous fluoride, sodium hexametaphosphate, and zinc lactate

dentifrice group exhibited a statistically significant 14.1%

lower plaque index score, both after six weeks of product use

(p ≤ 0.05).

No adverse events were observed by the examining dentist nor

noted by the subjects during the study.

Discussion There are many dentifrices on the market today that claim to

provide multiple benefits to the consumer. Some dentifrices pro-

vide caries and tartar protection, other dentifrices provide caries

and sensitivity protection, while others provide caries, plaque,

and gingivitis protection.

Colgate Total Toothpaste was first marketed in the early 1990s.

Since the inception of the original 0.3% triclosan, 2.0%

PVM/MA copolymer, 0.243% sodium fluoride dentifrice, sev-

eral product variants have been introduced into the market-

place. These variants all maintained the same combination of

active ingredients. The efficacy, mode of action, and safety of a

triclosan/PVM/MA copolymer/sodium fluoride dentifrice have

been researched and confirmed in over 200 articles in the

literature.4

Recently, a dentifrice claiming multiple benefits was intro-

duced into the marketplace. Its active ingredient for both caries

and plaque/gingivitis benefits is 0.454% stannous fluoride, with

sodium hexametaphosphate and zinc lactate. There has been

some ambiguity in the literature with regard to antibacterial and

antimicrobial-based benefits, such as plaque and gingivitis re-

ductions, that are ascribed to stannous fluoride. This variability

may be primarily related to the inherent instability of stannous

fluoride in the aqueous medium of dentifrices.26 In addition, it has

been widely reported that prolonged use of stannous fluoride

products causes dental staining.19

This examiner-blind, three-treatment clinical study provided

a comparison of the plaque and gingivitis efficacy of Colgate To-

tal Toothpaste to Crest Pro-Health dentifrice, and Crest Cavity

Protection toothpaste as a negative control. The results from the

study indicated that after six weeks:

• all three dentifrice groups exhibited statistically significant

reductions from baseline in gingival and plaque index scores;

Table IV

Summary of the Six-Week Plaque Index Scores for Subjects Who Completed the Six-Week Clinical Study


Analysis vs. Crest Pro-Health vs. Negative Control








1Colgate Total Toothpaste.2Crest Pro-Health Toothpaste.3 Crest Cavity Protection Toothpaste.4Percent reduction exhibited by the six-week mean relative to the baseline mean. A positive value indicates a lower plaque score at the six-week examination.5Significance of paired t-test comparing the baseline and six-week plaque index scores.6Difference between six-week means expressed as a percentage of the six-week mean for Crest Pro-Health Toothpaste. A positive value indicates a lower plaque score

for Colgate Total Toothpaste than for Crest Pro-Health Toothpaste.7Significance of post-ANCOVA comparison of baseline-adjusted means.8Difference between six-week means expressed as a percentage of the six-week mean for Crest Cavity Protection Toothpaste. The higher the percent difference the

greater the plaque efficacy for the dentifrice.


• both the Colgate Total Toothpaste group and the Crest Pro-

Health dentifrice group exhibited a statistically significantly

lower gingival index score (25.3% and 8.1%, respectively)

and plaque index score (33% and 14.1%, respectively),

compared to the Crest Cavity Protection toothpaste group.

• the Colgate Total Toothpaste group exhibited a statistically

significantly lower gingival index score (18.7%) and sta -

tistically significantly lower plaque index score (22%) com-

pared to the Crest Pro-Health dentifrice group.

ConclusionThe results from this study confirm the results of previous clin-

ical studies that a dentifrice containing 0.3% triclosan, 2.0%

PVM/MA copolymer, and 0.243% sodium fluoride is effica-

cious in reducing gingivitis and supragingival plaque.

The results from this research, utilizing a head-to-head com-

parison of two commercially available dentifrices, also show

that the dentifrice containing 0.3% triclosan, 2.0% PVM/MA

copolymer, and 0.243% sodium fluoride provides a greater level

of antiplaque and antigingivitis efficacy than does a dentifrice

containing 0.454% stannous fluoride, sodium hexametaphos-

phate, and zinc lactate.

Acknowledgment: This study was supported by the Colgate- Palmolive Company.


contact Patricia Chaknis—[email protected].

References1. Newman MG, Takei HH, Carranza FA, eds. Carranza’s Clinical Periodon-

tology 9th ed. WB Saunders Company, Philadelphia, pp. 96-167, 2001.

2. Oral Health of United States Adults. The National Survey of Oral Health

in US Employed Adults and Seniors. Washington, DC: Public Health Ser-

vice; NIH Publication 87-2868, 1987.

3. Jeffcoat MK. Prevention of periodontal diseases in adults: strategies for the

future. Prev Med 1994;23:704-708.

4. Blinkhorn A, Bartold PM, Cullinan MP, Madden TE, Marshall RI, Raphael


management of periodontal disease. Br Dent J 2009;207:117-125.

5. Albandar JM. Epidemiology and risk factors of periodontal disease. Dent

Clin North Am 2005;49:517-532.

6. Moore WE, Holdeman LV, Cato EP, Smibert RM, Burmeister JA, Ranney

RR. Bacteriology of moderate (chronic) periodontitis in mature adult humans.

Infect Immun 1983;42:510-515.

7. Paster BJ, Boches SK, Galvin JL, Ericson RE, Lau CN, Levanos VA,

Sahasrabudhe A, Dewhirst FE. Bacterial diversity in human subgingival

plaque. J Bacteriol 2001;183:3770-3783.

8. Kolenbrander PE. Oral microbial communities: biofilms, interactions, and

genetic systems. Ann Rev Microbiol 2000;54:413-437.

9. Taylor G. Consensus statement on oral and systemic health. Inside Dent

2006;2(Spec Iss)1-6.

10. Iacono VJ, Aldredge WA, Lucks H, Schwartzstein S. Modern supragingival

plaque control. Int Dent J 1998;48(Suppl 1):290-297.

11. http://ada.org/public/topics/cleaning.asp, 2010.

12. O’Mullane D. New agents in the chemical control of plaque and gingivitis

reaction paper. J Dent Res 1992;71:1455-1456.

13, Christersson LA, Grossi SG, Dunford RG, Machtei EE, Genco RJ. Dental

plaque and calculus: risk indicators for their formulation. J Dent Res 1992;

71:1425-1430.

14. Lindhe J. Triclosan/copolymer/fluoride dentifrices. A new technology for the

prevention of plaque, calculus, gingivitis and caries. Am J Dent 1990;3(Spec

Iss):S3-S4.

15. Gaffar A, Nabi N, Kashaba B, Williams M, Herles, S, Olsen S, Afflitto J.

Antiplaque effects of dentifrices containing triclosan/copolymer/NaF system

versus triclosan dentifrices without the copolymer. Am J Dent 1990;3(Spec

Iss):S7-S14.

16. Nabi N, Mukerjee C, Schmid R, Gaffar A. In vitro and in vivo studies on

triclosan/PVM/MA copolymer/NaF combination as an anti-plaque agent. Am

J Dent 1989;2(Spec Iss):197-206.

17. Panagakos FS, Volpe AR, Petrone ME, DeVizio W, Davies RM, Proskin

HM. Advanced oral antibacterial/anti-inflammatory technology: A com-

prehensive review of the clinical benefits of a triclosan/copolymer/fluoride

dentifrice. J Clin Dent 2005;16(Suppl)S1-S19.

18. Correspondence on file, Colgate-Palmolive Company, New York, NY.

19. Tinanoff N. Review of the antimicrobial action of stannous fluoride. J Clin

Dent 1990;2:22-27.

20. Mankodi S, Lopez M, Smith I, Petrone DM, Petrone ME, Chaknis P, Proskin

HM. Comparison of two dentifrices with respect to efficacy for the control

of plaque and gingivitis, and with respect to extrinsic tooth staining: A six-

month clinical study on adults. J Clin Dent 2002;13:228-233.

21. Liu H, Segreto VA, Baker RA, Vastola KA, Ramsey LL, Gerlach RW. Anti -

calculus efficacy and safety of a novel whitening dentifrice containing sodium

hexametaphosphate: a controlled six-month clinical trial. J Clin Dent 2002;

13:25-28.

22. Löe H, Silness J. Periodontol disease in pregnancy. I. Prevalence and severity.

Acta Odontol Scand 1963;21:533-551.

23. Talbott K, Mandel ID, Chilton NW. Reduction of baseline gingivitis scores

with repeated prophylaxis. J Prev Dent 1977;4:28-29.

24. Quigley GA, Hein JW. Comparative cleansing efficiency of manual and

power brushing. J Am Dent Assoc 1962;65:26-29.

25. Turesky S, Gilmore ND, Glickman I. Reduced plaque formation by the

chloromethyl analogue of victamine C. J Periodontol 1970;41:41-43.

26. Tinanoff N. Progress regarding the use of stannous fluoride in clinical den-

tistry. J Clin Dent 1995;6(Spec Iss):37-40.

A Comparison of the Efficacy of a Triclosan/Copolymer/Sodium FluorideDentifrice, a Stannous Fluoride/Sodium Hexametaphosphate/Zinc LactateDentifrice, and a Sodium Fluoride Dentifrice for the Control of Established

Supragingival Plaque and Gingivitis: A Six-Week Clinical StudyFarid Ayad, BDS, DDS

Canadian Clinical Research Center

Mississauga, Ontario, Canada

Bernal Stewart, BS Eng, MSc Yun Po Zhang, PhD


Piscataway, NJ, USA



Rochester, NY, USA

Abstract• Objective: To compare the efficacy of a dentifrice containing 0.3% triclosan, 2.0% PVM/MA copolymer, and 0.243% sodium fluoride

in controlling established gingivitis and supragingival plaque to that of a commercially available dentifrice containing 0.454%

stannous fluoride, sodium hexametaphosphate, and zinc lactate, and a commercially available dentifrice containing 0.243% sodium

fluoride.

• Methods: Following a baseline examination for gingivitis and supragingival plaque, qualifying adult male and female subjects from

the Mississauga, Ontario, Canada area were randomized into three dentifrice groups. Subjects were instructed to brush their teeth

twice daily (morning and evening) for one minute with their assigned dentifrice and a soft-bristled toothbrush. Examinations for

gingivitis and supragingival plaque were repeated after six weeks of product use.

• Results: One-hundred eighty-two (182) subjects complied with the protocol and completed the study. Relative to the 0.243% sodium

fluoride dentifrice group, the 0.3% triclosan/2.0% PVM/MA copolymer/0.243% sodium fluoride dentifrice group exhibited statisti-

cally significant reductions in gingival index and supragingival plaque index scores of 26.5% and 29.4%, respectively, after six weeks

of product use. Similarly, relative to the 0.243% sodium fluoride dentifrice group, the 0.454% stannous fluoride/sodium hexa meta -

phosphate/zinc lactate dentifrice group exhibited statistically significant reductions in gingival index and plaque index scores of 12.7%

and 12.6%, respectively, after six weeks of product use. Further, relative to the 0.454% stannous fluoride/sodium hexametaphosphate/zinc

lactate dentifrice group, the 0.3% triclosan/2.0% PVM/MA copolymer/0.243% sodium fluoride dentifrice group exhibited statistically

significant reductions in gingival index and plaque index scores of 15.8% and 19.2%, respectively

• Conclusion: The overall results of this double-blind clinical study support the conclusion that a dentifrice containing 0.3% triclosan,

2.0% PVM/MA copolymer, and 0.243% sodium fluoride is efficacious for the control of established gingivitis and supragingival

plaque, and that it provides a greater level of efficacy for the control of gingivitis and supragingival plaque than does a dentifrice

containing 0.454% stannous fluoride, sodium hexametaphosphate, and zinc lactate.


111

IntroductionFluoride dentifrices have played a significant role in reducing

dental caries, and many dentifrices on the market today deliver

other oral health benefits, such as improvement in periodontal

health.1-5 It is widely accepted that the control of plaque and

gingivitis is the key to periodontal health. Controlling supragin-

gival plaque starts with mechanical removal by tooth brushing.6

The American Dental Association defines the maintenance of

good oral hygiene as tooth brushing for two minutes twice daily

plus floss ing once a day.7 However, it has been shown that self-

performed tooth brushing and flossing is not always sufficient to

maintain a healthy mouth.8 So manufacturers started looking at

different chemotherapeutic agents to incorporate into dentifrice

formulations that would provide antiplaque and/or anti gingivitis

efficacy.

One such agent is triclosan, a phenolic antibacterial agent

with low toxicity and a broad spectrum of activity, which has

been shown to be effective against both gram positive and gram

negative bacteria.9 Triclosan has been incorporated into a sodium

fluoride dentifrice in combination with a polyvinylmethyl ether/

maleic acid copolymer (PVM/MA copolymer) to ensure delivery

and retention of the triclosan on oral hard and soft tissues. This

dentifrice formulation (Colgate® Total® Toothpaste, Colgate-

Palmolive Co., New York, NY, USA) has been clinically proven

in numerous scientific publications to prevent and reduce plaque

and reduce gingivitis in the adult population.10,11 It has been


• were pregnant or breast feeding women, or individuals who

participated in any other clinical study or panel test within

the last month of the start of the study.

• used antibiotics at any time during the one-month period

prior to entering the study, were taking any prescription

medication that might interfere with the study outcome, or

received a dental prophylaxis during the two weeks prior to

the study’s baseline examination.

Prospective subjects reported to the clinical facility having re-

frained from any oral hygiene procedures for twelve hours, and

eating, drinking, and smoking for four hours prior to the visit.

Subjects signed an Informed Consent form, and were screened

by the dental examiner with respect to the inclusion/exclusion

criteria. Subjects who met the inclusion/exclusion criteria received

a baseline gingivitis and supragingival plaque examination and

an oral soft and hard tissue assessment.

Qualifying subjects were randomized into three treatment

groups which were balanced for baseline gingivitis and supragin-

gival plaque scores. The three dentifrices tested in this study were

as follows: 1) a commercially available dentifrice containing

0.3% triclosan, 2.0% PVM/MA copolymer, and 0.243% sodium

fluoride (Colgate Total Toothpaste); 2) a commercially available

dentifrice containing 0.454% stannous fluoride, sodium hexa -

metaphosphate, and zinc lactate (Crest Pro-Health Toothpaste);

and 3) a commercially available dentifrice containing 0.243%

sodium fluoride (Crest Cavity Protection Toothpaste).

Following treatment assignment, subjects were provided with

a soft-bristled toothbrush and their assigned dentifrice. All den-

tifrices were over-wrapped in their original package to maintain

the double-blind study design. Subjects were instructed to brush

their teeth with their assigned dentifrice and toothbrush twice

daily (morning and evening) for one minute, and to use only the

dentifrice and toothbrush provided. Subjects were allowed to

maintain routine oral hygiene procedures, such as flossing or us-

ing inter-dental stimulators. There were no restrictions regarding

diet or smoking during the course of the study, although subjects

were instructed to refrain from any oral hygiene procedures for

twelve hours, and eating, drinking, and smoking for four hours

prior to their six-week study examinations. Subjects returned

to the clinical facility for gingivitis and supragingival plaque

examinations after six weeks of product use. Additionally, at

each examination, subjects received an evaluation of their oral

soft tissue by the examining dentist, and were questioned for the

occur rence of any adverse events.

Clinical Scoring ProceduresLöe-Silness Gingival Index. Gingivitis was scored according

to the Löe-Silness Gingival Index. Each tooth was divided into

six surfaces, three facial and three lingual, as follows: 1) mesio-







1 = Mild inflammation—slight change in color and little change

in texture.

shown in long-term clinical studies to provide anticaries bene-

fits, and has been clinically proven to prevent the progression of

periodontitis.12

Colgate Total Toothpaste is the only toothpaste approved by

the US Food and Drug Administration for the prevention of

plaque and gingivitis, and is accepted by the American Dental

Association for the prevention of plaque and gingivitis.13

Stannous fluoride dentifrices have been shown to reduce

caries and improve plaque control and gingivitis.14,15 A stabi-

lized stannous fluoride/sodium hexametaphosphate/zinc lactate

dentifrice (Crest® Pro-Health® Toothpaste, Procter & Gamble

Co., Cincinnati, OH, USA) has been reported to have a signif-

icant benefit on plaque control and gingival health, and to reduce

further loss of attachment in patients with periodontitis.16,17

Stannous fluoride, like sodium fluoride, is a common ingredi-

ent found in dentifrices to reduce caries. Sodium hexameta -

phosphate has been reported in the literature to reduce calculus

formation.18

The objective of this six-week clinical study was to compare

the antiplaque and antigingivitis efficacy of three commercially

available dentifrices: a dentifrice containing 0.3% triclosan,

2.0% PVM/MA copolymer, and 0.243% sodium fluoride (Col-

gate Total) to a dentifrice containing 0.454% stannous fluoride,

sodium hexametaphosphate, and zinc lactate (Crest Pro-Health).

A fluoride dentifrice was included as a negative control (Crest®

Cavity Protection Toothpaste, Procter & Gamble Co., Cincinnati,

OH, USA). Gingivitis and plaque evaluations were conducted at

baseline and after six weeks of product use.

Materials and MethodsThis study employed a double-blind, randomized, three-treat-

ment, parallel-group design. Adult male and female subjects

from the Mississauga, Ontario, Canada area were enrolled into

the study based upon the following criteria:

• Subjects had to be between 18 and 70 years of age, in good

general health, and have signed an Informed Consent doc-

ument.

• Subjects were required to be available for the six-week du-

ration of the study.

• Subjects had to possess at least 20 uncrowned permanent

natural teeth (excluding third molars).

• Subjects were required to present at baseline a mean gingi-

val index score of at least 1.0 as determined by the use of the

Löe and Silness Gingival Index,19,20 and a mean plaque in-

dex score of at least 1.5 as determined by the use of the


Subjects were excluded from study participation if they:

• had partial removable dentures, orthodontic bands, or ad-

vanced periodontal disease (purulent exudate, tooth mobil-

ity, and/or extensive loss of periodontal attachment or alve-

olar bone).

• had tumor(s) of the soft or hard oral tissues, or five or more

carious lesions requiring immediate restorative treatment.

• had a history of allergies to personal care/consumer products

or their ingredients, or they could not refrain from eating or

drinking due to medical conditions for periods of up to four

hours.


2 = Moderate inflammation—moderate glazing, redness, edema,

and hypertrophy.

3 = Severe inflammation—marked redness and hypertrophy.

Tendency for spontaneous bleeding.



Quigley-Hein Plaque Index. Plaque was scored according to

the Turesky modification of the Quigley-Hein Plaque Index.

Each tooth was divided into six surfaces, three facial and three

lingual, as follows: 1) mesio-facial; 2) mid-facial; 3) disto-facial;

4) mesio-lingual; 5) mid-lingual; and 6) disto-lingual. Third mo-

lars and those teeth with cervical restorations or prosthetic



lowing criteria:

0 = No plaque.

1 = Separate flecks of plaque at the cervical margin.


vical margin.


than 1/3 of the side of the crown of the tooth.

4 = Plaque covering at least 1/3, but less than 2/3 of the side

of the crown of the tooth.

5 = Plaque covering 2/3 or more of the side of the crown of

the tooth.



Oral Soft and Hard Tissue Assessment. The dental exam-


dental light and dental mirror prior to each plaque and gingivi-

tis examination. This examination included an evaluation of the

soft and hard palate, gingival mucosa, buccal mucosa, mucogin-

gival fold areas, tongue, sublingual and submandibular areas,

salivary glands, and the tonsilar and pharyngeal areas.

Adverse Events. Adverse events were determined by verbal

indications from the subjects or by visual examination by the

dental examiner.

Statistical MethodsStatistical analyses were performed separately for the gingi-

val index and plaque index scores. Comparisons of the treatment

groups with respect to baseline gingival index and plaque index

scores, as well as for age, were performed using analyses of

variance (ANOVA). Within-treatment comparisons of the gin-

gival index and plaque index scores obtained at the six-week ex-

aminations versus baseline were performed using paired t-tests.

Comparisons between treatment groups with respect to gender

were performed using chi-square tests. Comparisons of the treat-

ment groups with respect to baseline-adjusted gingival index

and plaque index scores at the six-week examinations were

performed using analyses of covariance (ANCOVA). Post-

ANCOVA pair-wise comparisons of the gingival and plaque in-

dex scores were performed using the Tukey test for multiple

comparisons. All statistical tests of hypotheses were two-sided,


ResultsOne-hundred and eighty-two (182) subjects complied with

the protocol and completed the six-week clinical study. A sum-

mary of the gender and age of the population who completed the

study is presented in Table I. The treatment groups did not dif-

fer significantly with respect to either of these characteristics.

Throughout the study, no adverse effects on the oral hard or soft

tissues were observed by the examiner or reported by the subjects

when questioned.

Baseline DataLöe-Silness Gingival Index and Quigley-Hein Plaque Index.

Table II presents a summary of the gingival and plaque index

scores measured at baseline for subjects who completed the

study. The mean baseline gingival index scores were 1.81 for

the 0.3% triclosan/2.0% PVM/MA copolymer/0.243% sodium

fluoride dentifrice group, 1.82 for the 0.454% stannous fluoride/

sodium hexametaphosphate/zinc lactate dentifrice group, and

Table I

Summary of Gender and Age for Subjects



Dentifrice Male Female Total Mean Range

0.3% triclosan/

2.0% PVM/MA copolymer/

0.243% sodium fluoride1

22 39 61 35.59 18–65

0.454% stannous fluoride/20 41 61 33.43 18–68


zinc lactate2

0.243% sodium fluoride3 26 34 60 35.25 18–61

1Colgate Total Toothpaste.2Crest Pro-Health Toothpaste.3Crest Cavity Protection Toothpaste.

Table II




Baseline

Summary




0.454% stannous fluoride/Gingivitissodium hexametaphosphate/ 61 1.82 ± 0.21

zinc lactate2

0.243% sodium fluoride3 60 1.88 ± 0.26



Plaque0.454% stannous fluoride/

sodium hexametaphosphate/ 61 2.70 ± 0.24

zinc lactate2

0.243% sodium fluoride3 60 2.71 ± 0.32

1Colgate Total Toothpaste.2Crest Pro-Health Toothpaste.3Crest Cavity Protection Toothpaste.4No statistically significant difference was indicated among the three dentifrice

groups at baseline.


1.88 for the 0.243% sodium fluoride dentifrice group. The

mean baseline plaque index scores were 2.73 for the 0.3%


dentifrice group, 2.70 for the 0.454% stannous fluoride/sodium

hexametaphosphate/zinc lactate dentifrice group, and 2.71 for the

0.243% sodium fluoride dentifrice group. No statistically signifi -

cant differences were indicated among the dentifrice groups with

respect to gingival or plaque index scores at baseline.

Six-Week DataLöe-Silness Gingival Index. Table III presents a summary of

the gingival index scores measured at the six-week examinations.

The mean six-week gingival index scores were 1.33 for the 0.3%




0.243% sodium fluoride dentifrice group.

Comparisons vs. Baseline. The mean percent reductions from

baseline were 26.5% for the 0.3% triclosan/2.0% PVM/MA


the 0.454% stannous fluoride/sodium hexametaphosphate/zinc





0.454% stannous fluoride/sodium hexametaphosphate/zinc lactate

dentifrice group, the 0.3% triclosan/2.0% PVM/MA copolymer/

0.243% sodium fluoride dentifrice group exhibited a statisti-

cally significant 15.8% reduction in gingival index scores after

six weeks of product use (p ≤ 0.05).

Relative to the 0.243% sodium fluoride dentifrice group, the

0.3% triclosan/2.0% PVM/MA copolymer/0.243% sodium

fluoride dentifrice group exhibited a statistically significant

reduction in gingival index scores of 26.5%, while the 0.454%

stannous fluoride/sodium hexametaphosphate/zinc lactate

dentifrice group exhibited a statistically significant 12.7% lower

gingival index score, both after six weeks of product use

(p ≤ 0.05).

Quigley-Hein Plaque Index. Table IV presents a summary of

the plaque index scores measured at the six-week examinations.

The mean six-week plaque index scores were 1.85 for the 0.3%




sodium fluoride dentifrice group.

Comparisons vs. Baseline. The mean percent reductions from

baseline were 32.2% for the 0.3% triclosan/2.0% PVM/MA


the 0.454% stannous fluoride/sodium hexametaphosphate/zinc




Relative to 0.454% stannous fluoride/sodium hexametaphos-

phate/zinc lactate dentifrice group, the 0.3% triclosan/2.0%

PVM/MA copolymer/0.243% sodium fluoride dentifrice group

exhibited a statistically significant 19.2% reduction in plaque in-

dex scores after six weeks of product use (p ≤ 0.05).


0.243% sodium fluoride dentifrice group, the 0.3% triclosan/

2.0% PVM/MA copolymer/0.243% sodium fluoride dentifrice

group exhibited a statistically significant reduction in plaque in-

dex scores of 29.4%, while the 0.454% stannous fluoride/sodium

hexametaphosphate/zinc lactate dentifrice group exhibited a

statistically significant 12.6% lower gingival index score, both


No adverse events were observed by the examining dentist nor

noted by the subjects during the study.

Discussion The maintenance of an effective level of plaque control is the

cornerstone of any attempt to prevent and control periodontal

disease, but most people fail to achieve a level of oral hygiene

Table III

Summary of the Six-Week Gingival Index Scores for Subjects Who Completed the Six-Week Clinical Study


Analysis vs. Crest Pro-Health vs. Crest Cavity Protection








1Colgate Total Toothpaste.2Crest Pro-Health Toothpaste.3Crest Cavity Protection Toothpaste.4Percent reduction exhibited by the six-week mean relative to the baseline mean. A positive value indicates a lower gingivitis score at the six-week examination.5Significance of paired t-test comparing the baseline and six-week gingival index scores.6Difference between six-week means expressed as a percentage of the six-week mean for Crest Pro-Health Toothpaste. A positive value indicates a lower gingivitis score

for Colgate Total Toothpaste than for Crest Pro-Health Toothpaste.7Significance of post-ANCOVA comparison of baseline-adjusted means.8Difference between six-week means expressed as a percentage of the six-week mean for Crest Cavity Protection Toothpaste. The higher the percent difference the greater

the gingivitis efficacy for the dentifrice.


commensurate with periodontal health.23,24 Periodontal diseases

are initiated by plaque bacteria and, consequently, much re-

search has focused on the possibility of enhancing oral hygiene

by incorporating chemotherapeutic agents into dentifrice for-

mulations.25 The effectiveness of a dentifrice formulation con-

taining 0.3% triclosan and 2.0% copolymer in delivering a more

effective level of plaque control and periodontal health has been

demonstrated in numerous clinical trials and documented in nar-

rative and systematic reviews.3-5,26,27 Dentifrices containing sta-

bilized stannous fluoride have also been shown to improve plaque

control and gingivitis in studies of six months’ duration.28-31

This double-blind, parallel, three-treatment clinical study pro-

vided a comparison of the plaque and gingivitis efficacy of a

clinically documented, commercially available dentifrice for-

mulation containing 0.3% triclosan, 2.0% PVM/MA copolymer,

and 0.243% sodium fluoride (Colgate Total Toothpaste) to a

commercially available dentifrice formulation containing 0.454%

stannous fluoride, sodium hexametaphosphate, and zinc lac-

tate (Crest Pro-Health Toothpaste). The third dentifrice in the

study was a commercially available dentifrice containing

0.243% sodium fluoride, used as a negative control (Crest Cavity

Protection Toothpaste).

The results from the study indicated that after six weeks’ use

of the dentifrices:

• All three dentifrice groups exhibited statistically signifi-

cant reductions from baseline in gingival and plaque index

scores.

• Both the Colgate Total dentifrice group and the Crest Pro-

Health dentifrice group exhibited a statistically significantly

lower gingival index score (26.5% and 12.7%, respectively)

and plaque index score (29.4% and 12.6%, respectively)

compared to the Crest Cavity Protection dentifrice group.

• The Colgate Total dentifrice group exhibited a statistically

significant lower gingival index score (15.8%) and plaque

index score (19.2%) compared to the Crest Pro-Health den-

tifrice group.

ConclusionThe results from this study confirm the results of many

previous clinical studies that a dentifrice containing 0.3%

triclosan, 2.0% PVM/MA copolymer, and 0.243% sodium

fluoride is efficacious in reducing gingivitis and supragingival

plaque.

The results from this research also show that a dentifrice con-

taining 0.3% triclosan, 2.0% PVM/MA copolymer, and 0.243%

sodium fluoride provides a greater level of efficacy than does a


metaphosphate, and zinc lactate.

Acknowledgment: This study was supported by the Colgate- Palmolive Company


contact Bernal Stewart—[email protected].

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containing triclosan and polyvinyl-methyl ether maleic acid copolymer in

improving plaque control and gingival health. A systematic review. J Clin

Perio dontol 2004;31:1029-1033.

4. Hioe KP, van der Weijden GA. The effectiveness of self-performed me-

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Hyg 2005;3:192-204.

5. Gunsolley JC. A meta-analysis of six-month studies of antiplaque and anti -

gingivitis agents. J Am Dent Assoc 2006;137:1649-1657.

6. http://ada.org/public/topics/cleaning.asp, 2010.

7. Axelsson P, Lindhe J, Nyström B. On the prevention of caries and perio -

dontal disease. Results of a 15-year longitudinal study in adults. J Clin

Perio dontol 1991;18:182-189.

8. O’Mullane D. New agents in the chemical control of plaque and gingivitis:

reaction paper. J Dent Res 1992;71:1455-1456.



Table IV

Summary of the Six-Week Plaque Index Scores for Subjects Who Completed the Six-Week Clinical Study


Analysis vs. Crest Pro-Health vs. Crest Cavity Protection





0.454% stannous fluoride/sodium61 2.29 ± 0.46 15.2% p < 0.05 — — 12.6% p < 0.05

hexametaphosphate/zinc lactate 2


1Colgate Total Toothpaste.2Crest Pro-Health Toothpaste.3Crest Cavity Protection Toothpaste.4Percent reduction exhibited by the six-week mean relative to the baseline mean. A positive value indicates a lower plaque score at the six-week examination.5Significance of paired t-test comparing the baseline and six-week plaque index scores.6Difference between six-week means expressed as a percentage of the six-week mean for Crest Pro-Health Toothpaste. A positive value indicates a lower plaque score for

Colgate Total Toothpaste than for Crest Pro-Health Toothpaste.7Significance of post-ANCOVA comparison of baseline-adjusted means.8Difference between six-week means expressed as a percentage of the six-week mean for Crest Cavity Protection Toothpaste. The higher the percent difference the greater

the plaque efficacy for the dentifrice.


Iss):S3-S4.

10. Gaffar A, Nabi N, Kashaba B, Williams M, Herles S, Olsen S, Afflitto J.

Anti plaque effects of dentifrices containing triclosan/copolymer/NaF system

versus triclosan dentifrices without the copolymer. Am J Dent 1990;3(Spec

Iss):S7-S14.



J Dent 1989;2(Spec Iss):197-206.


HM. Advance oral antibacterial/anti-inflammatory technology: A compre-

hensive review of the clinical benefits of a triclosan/copolymer/fluoride

dentifrice. J Clin Dent 2005;16(Suppl)S1-S19.

13. Correspondence on file, Colgate-Palmolive Company, New York, NY.

14. Faller RV, Best JM, Featherstone JD, Barrett-Vespone NA. Anticaries effi-

cacy of an improved stannous fluoride toothpaste. J Clin Dent 1995;6(Spec

Iss):89-96.

15. Paraskevas S, van der Weijden GA. A review of the effects of stannous fluo -

ride on gingivitis. J Clin Periodontol 2006;33:1-13.

16. Mankodi S, Bartizek RD, Winston JL, Biesbrock AR, McClanahan SF, He

T. Anti-gingivitis efficacy of a stabilized 0.454% stannous fluoride/sodium

hexametaphosphate dentifrice. J Clin Periodontol 2005;32:75-80.

17. Papas A, He T, Martuscelli G, Singh M, Bartizek RD, Biesbrock AR. Com-

parative efficacy of stabilized stannous fluoride/sodium hexametaphosphate

dentifrice and sodium fluoride/triclosan/copolymer dentifrice for the pre-

vention of periodontitis in xerostomic patients: A 2-year randomized clini-

cal trial. J Periodontol 2007;78:1505-1514.

18. Liu H, Segreto VA, Baker RA, Vastola KA, Ramsey LL, Gerlach RW. Anti -

calculus efficacy and safety of a novel whitening dentifrice containing

sodium hexametaphosphate: A controlled six-month clinical trial. J Clin

Dent 2002;13:25-28.

19. Löe H, Silness J. Periodontol disease in pregnancy. I. Prevalence and sever-

ity. Acta Odontol Scand 1963;21:533-551.


with repeated prophylaxis. J Prev Dent 1977;4:28-29.

21. Quigley GA, Hein JW. Comparative cleansing efficiency of manual and

power brushing. J Am Dent Assoc 1962;65:26-29.



23. Claydon NC. Current concepts in toothbrushing and interdental cleaning.

Perio dontol 2000 2008;48:10-22.

24. Löe H. Oral hygiene in the prevention of caries and periodontal disease. Int

Dent J 2000;50:129-139.

25. Paraskevas S. Randomized controlled clinical trials on agents used for

chemical plaque control. Int J Dent Hyg 2005;3:162-178.

26. Volpe AR, Petrone ME, DeVizio W, Davies RM, Proskin HM. A review of

the plaque, gingivitis, calculus and caries clinical efficacy studies with a fluoride

dentifrice containing triclosan and PVM/MA copolymer. J Clin Dent 1996;7

(Suppl):S1-S14.

27. Blinkhorn A, Bartold PM, Cullinan MP, Madden TE, Marshall RI, Raphael


management of periodontal disease? Br Dent J 2009;207:117-125.

28. Mankodi S, Petrone DM, Battista G, Petrone ME, Chaknis P, DeVizio W,

Volpe AR, Proskin HM. Clinical efficacy of an optimized stannous fluoride

dentifrice, Part 2: A 6-month plaque/gingivitis clinical study, northeast

USA. Compend Contin Educ Dent 1997;18(Spec Iss):10-15.

29. Williams C, McBride S, Bolden TE, Mostler K, Petrone DM, Petrone ME,

Chaknis P, DeVizio W, Volpe AR, Proskin HM. Clinical efficacy of an

optimized stannous fluoride dentifrice, Part 3: A 6-month plaque/gingivitis

study, southeast USA. Compend Contin Educ Dent 1997;18(Spec Iss):16-

20.

30. Beiswanger BB, Doyle PM, Jackson RD, Mallatt ME, Mau M, Bollmer BW,

Crisanti MM, Guay CB, Lanzalaco AC, Lukacovic MF, Majeti S, Mc-

Clanahan SF. The clinical effect of dentifrices containing stabilized stannous

fluoride on plaque formation and gingivitis. A six-month study with ad

libitum brushing. J Clin Dent 1995;6(Spec Iss):46-53.

31. Perlich MA, Bacca LA, Bollmer BW, Lanzalaco AC, McClanahan SF,

Sewak LK, Beiswanger BB, Eichold WA, Hull JR, Jackson RD, Mau MS.

The clinical effect of a stabilized stannous fluoride dentifrice on plaque for-

mation, gingivitis and gingival bleeding: a six-month study. J Clin Dent 1995;

6(Spec Iss):54-58.

Comparative Investigation of the Efficacy ofTriclosan/Copolymer/Sodium Fluoride and Stannous Fluoride/Sodium

Hexametaphosphate/Zinc Lactate Dentifrices for the Control of EstablishedSupragingival Plaque and Gingivitis in a Six-Month Clinical Study

Augusto Elias Boneta, DMD, MSD Mauricio Montero Aguilar, DDS, MSc

Ferdinand Lugo Romeu, DMD, MS

University of Puerto Rico

San Juan, Puerto Rico

Bernal Stewart, BS, MS William DeVizio, DMD


Piscataway, NJ, USA



Rochester, NY, USA

Abstract

• Objective: This double-blind clinical study, conducted at the University of Puerto Rico, San Juan, Puerto Rico, was designed to

compare the efficacy of two commercially available dentifrices for the control of supragingival plaque and gingivitis.

• Methods: Qualifying adult male and female subjects from the San Juan, Puerto Rico area were randomly assigned to one of two

treatment groups: 1) a commercially available dentifrice containing 0.3% triclosan, 2.0% PVM/MA copolymer, and 0.243%

sodium fluoride (Colgate® Total®); and 2) a commercially available dentifrice containing 0.454% stannous fluoride, sodium hexa-

metaphosphate, and zinc lactate (Crest® Pro-Health®). All subjects received an oral soft and hard tissue examination, and were

dispensed their assigned dentifrice product, along with a soft-bristled adult toothbrush for home use. Subjects were instructed to

brush their teeth for one minute, twice daily (morning and evening), using only the dentifrice provided. Examinations for supra -

gingival plaque and gingivitis, and oral soft and hard tissue assessments were repeated after six weeks, three months, and six months

of product use.

• Results: One-hundred and nine (109) subjects complied with the protocol and completed the six-month examinations. At the six-

month examination, both treatment groups exhibited statistically significant reductions from baseline with respect to supragingival

plaque and gingivitis scores. Relative to the Crest Pro-Health Toothpaste group, the Colgate Total Toothpaste group exhibited sta-

tistically significant reductions in supragingival plaque index scores of 18.5%, 20.7%, and 25.8% after six weeks, three months,

and six months of product use, respectively. For gingival index scores, statistically significant reductions of 20.5%, 18.9%, and 17.1%

were exhibited after six weeks, three months, and six months of product use, respectively.

• Conclusion: The results of this double-blind clinical study support the conclusion that a dentifrice containing 0.3% triclosan, 2.0%

PVM/MA copolymer, and 0.243% sodium fluoride provides a significant reduction in established supragingival plaque and gin-

givitis, as compared to a dentifrice containing 0.454% stannous fluoride, sodium hexametaphosphate, and zinc lactate when used

over a period of six months.


117

IntroductionDental plaque-induced gingivitis is inflammation of the gin-

gival tissues characterized by a change in color, texture, and a

tendency to bleed upon probing.1,2 Unlike periodontitis, there is

no tissue attachment loss to the tooth structure in gingivitis.

However, if unattended, gingivitis can lead to periodontitis and,

eventually, to tooth loss.3

Epidemiological studies have reported a high prevalence of

gingivitis in adult populations in the US, with variations ob-

served in different ethnic groups and gender. According to the US

National Survey of Employed Adults conducted in 1985, 47% of

men and 39% of women presented bleeding on probing in at least

one site.4 An apparent improvement in gingival health in adults

has been reported since the First National Survey in Adults con-

ducted in 1960-1962. The prevalence reported in that first study

was 85% in men, 79% in women, while years later a prevalence

of 50% in adults was reported in the NHANES III (1988-1994).

More recently, Dye, et al. concluded that data from NHANES III

and NHANES 1999–2004 indicates that periodontitis has de-

clined across nearly all major groups in the US.5,6 Findings from

the NHANES7 revealed that Hispanics in the US had a higher

prevalence of gingivitis than Caucasian adults in the US.

The scientific literature supports that the accumulation of

dental plaque, or what is commonly referred to now as the oral


• Subjects needed to be available for the duration of the study,

and to sign an Informed Consent form.

• Subjects were required to present, at baseline, a mean Löe-

Silness Gingival Index1,2 score of at least 1.0, and a mean

plaque index score of 1.5 or greater, as determined by the


• Subjects were excluded from the study if they had ortho-

dontic bands, presence of partial dentures, tumors of the soft

or hard tissues of the oral cavity, advanced periodontal dis-

ease (purulent exudates, tooth mobility, and/or extensive loss

of periodontal attachment or alveolar bone), five or more car-

ious lesions requiring immediate restorative treatment, or a

history of allergies to oral care/personal care consumer prod-

ucts or their ingredients. Additionally, pregnant or lactating

women, individuals with a history of alcohol or drug abuse,

or individuals who had participated in any other clinical

study or who had used antibiotics any time within one month

preceding the study were excluded from participation.

• Subjects who received a dental prophylaxis within two

weeks prior to the baseline examination, or subjects with ex-

isting medical conditions or conditions which precluded

them from not eating and drinking for periods up to four

hours, or who were taking any medications that might in-

terfere with the study outcome were also excluded from the

study.

Prospective study subjects reported to the clinical facility hav-

ing refrained from all oral hygiene procedures for 12 hours, and

having refrained from eating, drinking, or smoking for four

hours prior to their examination. All prospective subjects who

met the inclusion/exclusion criteria received a baseline plaque

and gingivitis examination, along with an oral soft and hard tis-

sue assessment.

Qualifying subjects were randomly assigned to one of the

two study treatments:

1. A commercially available dentifrice containing 0.3%

triclosan, 2.0% PVM/MA copolymer, and 0.243% sodium

fluoride (Colgate Total Toothpaste).

2. A commercially available dentifrice containing 0.454%

stannous fluoride, sodium hexametaphosphate, and zinc

lactate (Crest® Pro-Health® Toothpaste, Procter & Gamble

Co., Cincinnati, OH, USA).

Following their assignment to a study group, all subjects were

provided with their assigned dentifrice and an adult soft-bristled

toothbrush for home use. All dentifrice products were supplied

in their original packaging and overwrapped with a white label

to mask the product’s identity. Subjects were instructed to brush

their teeth for one minute, twice daily (morning and evening), us-

ing only the dentifrice and toothbrush provided, and to refrain

from any other oral hygiene procedures throughout the duration

of the study. There were no restrictions regarding diet or smok-

ing habits during the course of the study.

Subjects returned to the clinical facility for plaque and gin-

givitis examinations and oral soft and hard tissue assessments

after six weeks, three months, and six months of product use. All

examinations were performed by the same dental examiner

using the same procedures as employed at baseline. Training and

standardization sessions were conducted before the beginning of

biofilm, in susceptible hosts is associated with gingivitis and

perio dontitis,8 considering it a cause and effect relationship.4

Plaque or biofilm formation is a process that consists of a for-

mation of the acquired pellicle on the tooth surface. There is then

the initial adhesion and attachment of gram positive bacteria, fol-

lowed by microbial colonization by gram negative anaerobic

bacteria. This leads to an organized and structured biofilm. Bac-

terial plaque is the primary cause of gingivitis in conjunction with

other predisposing factors, such as tobacco, calculus, and ortho -

dontic therapy, among others.9

Therefore, therapy for gingivitis should be directed primarily

at the reduction of oral bacteria and calcified and non-calcified

deposits.10 Optimal oral hygiene, brushing twice daily, and floss-

ing as recommended by the ADA, all contribute to good oral

health.11 However, a large percentage of the population is unable

to adequately clean their teeth. In a clinical study, more than 66%

of subjects who stated that they brushed their teeth twice a day

presented with dental plaque.8 Several factors, such as the brush-

ing technique, duration of brushing, and failure to remove plaque

from interproximal areas of posterior teeth and lingual areas,

affect and impede mechanical plaque removal.12

The high prevalence of gingivitis reported in the US and other

parts of the world4 and its possible development into periodon-

titis, combined with the evidence from clinical studies showing

the difficulties encountered in adequately removing dental

plaque,8,12 and the recent evidence relating periodontal disease

and atherosclerotic disease,13 all support the use of chemother-

apeutic agents in dental products for plaque control.

Chemotherapeutic agents with antibacterial properties, such as

triclosan, have been added to fluoride-containing toothpastes to

reduce plaque and gingivitis. Triclosan is a nonionic, bisphenolic

germicidal agent. It has low toxicity, a broad spectrum of activ-

ity, and is effective against both gram positive and gram nega-

tive bacteria.14 Colgate® Total® Toothpaste (Colgate-Palmolive

Co., New York, NY, USA) also contains the copolymer,

PVM/MA (polyvinylmethyl ether/maleic acid), which, when

combined with the triclosan, ensures the delivery and retention

of triclosan to hard and soft tissues.15,16 The combination of 0.3%

triclosan, 2.0% PVM/MA copolymer, and 0.243% sodium fluo-

ride, Colgate Total Toothpaste, has been tested in clinical studies

and shown to significantly reduce plaque and gingivitis.17,18

The objective of this six-month randomized clinical trial was

to compare the efficacy of a dentifrice containing 0.3% triclosan,

2.0% PVM/MA copolymer, and 0.243% sodium fluoride to a


metaphosphate, and zinc lactate for the control of established

supragingival plaque and gingivitis.

Materials and MethodsThis clinical study, conducted at the School of Dental Medi-

cine of the University of Puerto Rico in San Juan, Puerto Rico,

employed a double-blind, randomized, two-treatment, parallel-

group design. Adult male and female subjects from the San Juan

area were enrolled into the study based upon the following criteria:

• Subjects had to be between the ages of 21 and 70, in gen-

erally good health, and possess a minimum of 20 uncrowned

permanent natural teeth (excluding third molars).


the study’s data collection visits at the University of Puerto Rico

School of Dental Medicine. The dental examiner and a back-up

examiner were trained and standardized on the plaque and gingi -

vitis indices employed in the study by a periodontist who served

as the reference examiner. At the six-week, three-month, and six-

month examinations, in addition to visual examinations by the

dental examiner, subjects were also interviewed to determine if

they experienced any adverse events during the study period.

Clinical Scoring Procedures

Plaque Assessment. Plaque was scored according to the

Turesky modification of the Quigley-Hein Plaque Index. Each

tooth was divided into six surfaces, three facial and three lingual,

as follows: 1) mesio-facial; 2) mid-facial; 3) disto-facial;

4) mesio-lingual; 5) mid-lingual; and 6) disto-lingual. Third

molars and those teeth with cervical restorations or prosthetic



lowing criteria:

0 = No plaque.

1 = Separate flecks of plaque at the cervical margin of the

tooth.


vical margin of the tooth.


than 1/3 of the crown of the tooth.

4 = Plaque covering at least 1/3, but less than 2/3 of the crown

of the tooth.

5 = Plaque covering 2/3 or more of the crown of the tooth.

Whole-mouth mean scores were obtained by averaging the

values obtained over all scoreable surfaces in the mouth.

Gingivitis Assessment. Gingivitis was scored according to

the Löe-Silness Gingival Index. Each tooth was divided into six

surfaces, three facial and three lingual, as follows: 1) mesio-







1 = Mild inflammation: slight change in color and little change

in texture.

2 = Moderate inflammation: moderate glazing, redness,

edema, hypertrophy. Tendency to bleed upon probing.

3 = Severe inflammation: marked redness and hypertrophy.

Tendency to spontaneous bleeding.

Whole-mouth mean scores were obtained by averaging the

values obtained over all scoreable surfaces in the mouth.

Oral Soft and Hard Tissue Assessments. The dental exam-


dental light and dental mirror. This examination included an

assessment of the soft and hard palate, gingival mucosa, buccal

mucosa, mucogingival fold areas, tongue, sublingual and sub-

mandibular areas, salivary glands, and the tonsilar and pharyn-

geal areas of the mouth.

Adverse Events. Adverse events were obtained from an inter -

view with the subject and a dental examination by the investigator.

Statistical Methods

Statistical analyses were performed separately for the gingi-

val index and plaque index. Comparisons of the treatment groups

with respect to baseline plaque and gingivitis scores, as well as

for age, were performed using analyses of variance (ANOVA).

Comparisons between the treatment groups with respect to

gender were performed using chi-square tests. Within-treatment

comparisons of the plaque and gingivitis scores obtained at the

six-week, three-month, and six-month examinations versus base-

line were performed using paired t-tests. Comparisons of the

treatment groups with respect to baseline-adjusted plaque and

gingivitis scores at the six-week, three-month, and six-month

examinations were performed using analyses of covariance

(ANCOVA). All statistical tests of hypothesis were two sided,


ResultsOf the one-hundred and twenty-one (121) subjects who en-

tered the study, 109 subjects (90.1%) complied with the proto-

col and completed the six-month examination. The subjects who

did not complete the study were discontinued for reasons unre-

lated to the use of the study treatments. A summary of the age

and gender of the study population who completed the six-month

examination is presented in Table I. The treatment groups did not

differ significantly with respect to either of these characteristics.

Throughout the study, no adverse effects on the soft or hard tis-

sues of the oral cavity were observed by the examiner or reported

by the participants when questioned.

Baseline Data

Table II presents a summary of the plaque index and gingival

index scores measured at the baseline examination for those

subjects who completed the six-month examinations. For plaque

index, the mean baseline scores were 3.16 for the Colgate Total

Toothpaste group, and 3.19 for the Crest Pro-Health Toothpaste

group. For gingival index, the mean baseline scores were 2.17 for

the Colgate Total Toothpaste group, and 2.18 for the Crest Pro-

Health Toothpaste group. No statistically significant difference

was indicated between the treatment groups with respect to

plaque or gingival index scores at baseline.

Six-Week Data

Plaque Index. Table III presents a summary of the plaque

index scores measured after six weeks of product use.

The mean six-week plaque index scores were 2.12 for the

Colgate Total Toothpaste group, and 2.60 for the Crest Pro-Health

Table I

Summary of Age, Gender, and Smoking Status

for Subjects Who Completed the Clinical Study


Treatment Male Female Total Mean Range

Colgate Total Toothpaste1 18 36 54 40 21–63

Crest Pro-Health Toothpaste2 14 41 55 39 21–68

1A commercially available dentifrice containing 0.3% triclosan, 2.0% PVM/MA

copolymer, and 0.243% sodium fluoride.2A commercially available dentifrice containing 0.454% stannous fluoride,

sodium hexametaphosphate, and zinc lactate.


Toothpaste group. The mean percent reductions from baseline

were 32.9% for the Colgate Total Toothpaste group, and 18.5%

for the Crest Pro-Health Toothpaste group, both of which were

statistically significant.

Relative to the Crest Pro-Health Toothpaste group, the Colgate

Total Toothpaste group exhibited a statistically significant 18.5%

reduction in plaque index scores after six weeks of product use.

Gingival Index. Table IV presents a summary of the gingival

index scores measured after six weeks of product use.

The mean six-week gingival index scores were 1.40 for the








reduction in gingival index scores after six weeks of product

use.

Three-Month Data

Plaque Index. Table V presents a summary of the plaque index

scores measured after three months of product use.

The mean three-month plaque index scores were 1.95 for the








reduction in plaque index scores after three months of product

use.

Gingival Index. Table VI presents a summary of the gingival

index scores measured after three months of product use.

The mean three-month gingival index scores were 1.20 for the






Table II



Who Completed the Six-Month Clinical Study

Baseline

Summary


Plaque IndexColgate Total Toothpaste1 54 3.16 ± 0.64

Crest Pro-Health Toothpaste2 55 3.19 ± 0.56

Gingival IndexColgate Total Toothpaste1 54 2.17 ± 0.36

Crest Pro-Health Toothpaste2 55 2.18 ± 0.40

1A commercially available dentifrice containing 0.3% triclosan, 2.0% PVM/MA

copolymer, and 0.243% sodium fluoride.2A commercially available dentifrice containing 0.454% stannous fluoride,

sodium hexametaphosphate, and zinc lactate.3No statistically significant difference was indicated between the two treatment

groups at baseline with respect to either the Plaque Index or Gingival Index.

Table III

Summary of the Six-Week Plaque Index Scores for Subjects Who Completed the Six-Month Clinical Study

Six-WeekWithin-Treatment Analysis Between-Treatment Analysis

Summary Percent Percent

Treatment n (Mean ± SD) Reduction3 Sig.4 Difference5 Sig.6

Colgate Total Toothpaste1 54 2.12 ± 0.51 32.9% p < 0.0518.5% p < 0.05

Crest Pro-Health Toothpaste2 55 2.60 ± 0.57 18.5% p < 0.05

1A commercially available dentifrice containing 0.3% triclosan, 2.0% PVM/MA copolymer, and 0.243% sodium fluoride.2A commercially available dentifrice containing 0.454% stannous fluoride, sodium hexametaphosphate, and zinc lactate.3Percent reduction exhibited by the six-week mean relative to the baseline mean. A positive value indicates a lower plaque score at the six-week examination.4Significance of paired t-test comparing the baseline and six-week examinations.5Difference between six-week means expressed as a percentage of the six-week mean for Crest Pro-Health Toothpaste. A positive value indicates a lower plaque score for

Colgate Total Toothpaste than for Crest Pro-Health Toothpaste.6Significance of post-ANCOVA comparison of baseline-adjusted means.

Table IV

Summary of the Six-Week Gingival Index Scores for Subjects Who Completed the Six-Month Clinical Study

Six-WeekWithin-Treatment Analysis Between-Treatment Analysis





1A commercially available dentifrice containing 0.3% triclosan, 2.0% PVM/MA copolymer, and 0.243% sodium fluoride.2A commercially available dentifrice containing 0.454% stannous fluoride, sodium hexametaphosphate, and zinc lactate.3Percent reduction exhibited by the six-week mean relative to the baseline mean. A positive value indicates a lower gingivitis score at the six-week examination.4Significance of paired t-test comparing the baseline and six-week examinations.5Difference between six-week means expressed as a percentage of the six-week mean for Crest Pro-Health Toothpaste. A positive value indicates a lower gingivitis score

for Colgate Total Toothpaste than for Crest Pro-Health Toothpaste.6Significance of post-ANCOVA comparison of baseline-adjusted means.




reduction in gingival index scores after three months of product

use.

Six-Month Data

Plaque Index. Table VII presents a summary of the plaque

index scores measured after six months of product use.

The mean six-month plaque index scores were 1.75 for the








reduction in plaque index scores after six months of product use.

Gingival Index. Table VIII presents a summary of the gingi-

val index scores measured after six months of product use.

The mean six-month gingival index scores were 1.16 for the








reduction in gingival index scores after six months of product use.

No significant adverse events were reported or observed dur-

ing this study.

Table V

Summary of the Three-Month Plaque Index Scores for Subjects Who Completed the Six-Month Clinical Study

Three-MonthWithin-Treatment Analysis Between-Treatment Analysis





1A commercially available dentifrice containing 0.3% triclosan, 2.0% PVM/MA copolymer, and 0.243% sodium fluoride.2A commercially available dentifrice containing 0.454% stannous fluoride, sodium hexametaphosphate, and zinc lactate.3Percent reduction exhibited by the three-month mean relative to the baseline mean. A positive value indicates a lower plaque score at the three-month examination.4Significance of paired t-test comparing the baseline and three-month examinations.5Difference between three-month means expressed as a percentage of the three-month mean for Crest Pro-Health Toothpaste. A positive value indicates a lower plaque

score for Colgate Total Toothpaste than for Crest Pro-Health Toothpaste.6Significance of post-ANCOVA comparison of baseline-adjusted means.

Table VI

Summary of the Three-Month Gingival Index Scores for Subjects Who Completed the Six-Month Clinical Study

Three-MonthWithin-Treatment Analysis Between-Treatment Analysis





1A commercially available dentifrice containing 0.3% triclosan, 2.0% PVM/MA copolymer, and 0.243% sodium fluoride.2A commercially available dentifrice containing 0.454% stannous fluoride, sodium hexametaphosphate, and zinc lactate.3Percent reduction exhibited by the three-month mean relative to the baseline mean. A positive value indicates a lower gingivitis score at the three-month examination.4Significance of paired t-test comparing the baseline and three-month examinations.5Difference between three-month means expressed as a percentage of the three-month mean for Crest Pro-Health Toothpaste. A positive value indicates a lower gingivitis

score for Colgate Total Toothpaste than for Crest Pro-Health Toothpaste.6Significance of post-ANCOVA comparison of baseline-adjusted means.

Table VII

Summary of the Six-Month Plaque Index Scores for Subjects Who Completed the Six-Month Clinical Study

Six-MonthWithin-Treatment Analysis Between-Treatment Analysis





1A commercially available dentifrice containing 0.3% triclosan, 2.0% PVM/MA copolymer, and 0.243% sodium fluoride.2A commercially available dentifrice containing 0.454% stannous fluoride, sodium hexametaphosphate, and zinc lactate.3Percent reduction exhibited by the six-month mean relative to the baseline mean. A positive value indicates a lower plaque score at the six-month examination.4Significance of paired t-test comparing the baseline and six-month examinations.5Difference between six-month means expressed as a percentage of the six-month mean for Crest Pro-Health Toothpaste. A positive value indicates a lower plaque score



Discussion and Conclusion The present randomized clinical trial compared the efficacy of

two commercially available dentifrices in the control of estab-

lished supragingival plaque and gingivitis. This study provided

a six-week, three-month, and six-month whole-mouth evaluation

of the plaque and gingivitis efficacy of a dentifrice containing

0.3% triclosan, 2.0% PVM/MA copolymer, and 0.243% sodium

fluoride (Colgate Total Toothpaste), and a dentifrice containing


lactate (Crest Pro-Health Toothpaste) when used for one minute,

twice daily.

Toothpastes containing the combination of 0.3% triclosan/

2.0% copolymer/0.243% sodium fluoride, have been clinically

proven in numerous studies to significantly reduce plaque and

gingivitis.17,21 In addition, antimicrobial tests22 have also been

employed to evaluate the effects of oral hygiene products. Ha-

raszthy, et al.8 assessed the antimicrobial efficacy of commercial

dentifrices containing fluoride, stannous fluoride, and triclosan/

copolymer/fluoride on the microorganisms frequently present in

the oral cavity, and demonstrated that the dentifrice containing

the triclosan/copolymer/fluoride (Colgate Total) resulted in a

significantly higher inhibition of bacterial growth as compared

to both the stannous fluoride (Crest Pro-Health) and the sodium

fluoride dentifrices (p < 0.00005). According to Haraszthy, et al.8

“Colgate Total had a substantially greater effect on gram nega-

tive pathogens (including Aggregatibacter actinomycetemcomi-

tans, E. corrodens, and F. Nucleatum), gram positive organisms,

such as streptococci, oral yeast, such as Candida albicans, and

non-oral bacteria, including staphylococci and bacillus spp.”

In the present study, subjects assigned to both the Colgate Total

Toothpaste group and the Crest Pro-Health Toothpaste group

exhibited statistically significant reductions from baseline with

respect to supragingival plaque and gingivitis scores at the six-

week, three-month, and six-month examinations.


Total Toothpaste group exhibited statistically significant reductions

in supragingival plaque index scores of 18.5%, 20.7%, and 25.8%

after six weeks, three months, and six months of product use, re-

spectively. For gingival index scores, statistically significant re-

ductions of 20.5%, 18.9%, and 17.1% were exhibited after the

same time intervals, respectively.

The results of this double-blind clinical study support the

conclusion that a dentifrice containing 0.3% triclosan, 2.0%

PVM/MA copolymer, and 0.243% sodium fluoride provides a

significant reduction in established supragingival plaque and

gingivitis when used over a period of six months.

Acknowledgment: This study was supported by the Colgate-Palmolive Company.


contact Bernal Stewart—[email protected].

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Table VIII

Summary of the Six-Month Gingival Index Scores for Subjects Who Completed the Six-Month Clinical Study

Six-MonthWithin-Treatment Analysis Between-Treatment Analysis





1A commercially available dentifrice containing 0.3% triclosan, 2.0% PVM/MA copolymer, and 0.243% sodium fluoride.2A commercially available dentifrice containing 0.454% stannous fluoride, sodium hexametaphosphate, and zinc lactate.3Percent reduction exhibited by the six-month mean relative to the baseline mean. A positive value indicates a lower gingivitis score at the six-month examination.4Significance of paired t-test comparing the baseline and six-month examinations.5Difference between six-month means expressed as a percentage of the six-month mean for Crest Pro-Health Toothpaste. A positive value indicates a lower gingivitis score


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brushing. J Am Dent Assoc 1962;65:26-29.



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supragingival plaque and gingivitis. J Clin Dent 2008;19:85-94

22. Fine DH. Chemical agents to prevent and regulate plaque development. Perio -

dontol 2000 1995;8:87-107.


Notes

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Contents

Superior Management of Plaque and Gingivitis Through the Useof a Triclosan/Copolymer Dentifrice ............................................................93

Sebastian Ciancio, Fotinos S. Panagakos

Evaluation of the Antimicrobial Activity of Dentifrices onHuman Oral Bacteria ....................................................................................96

Violet I. Haraszthy, Joseph J. Zambon, Prem K. Sreenivasan

Comparison of the Short-Term Antiplaque/Antibacterial Efficacy ofTwo Commercial Dentifrices ........................................................................101

Virginia Monsul Barnes, Rose Richter, William DeVizio

A Clinical Investigation of the Efficacy of Three CommerciallyAvailable Dentifrices for Controlling Established Gingivitisand Supragingival Plaque..................................................................................105

Surendra Singh, Patricia Chaknis, William DeVizio,

Margaret Petrone, Fotinos S. Panagakos, Howard M. Proskin

A Comparison of the Efficacy of a Triclosan/Copolymer/Sodium FluorideDentifrice, a Stannous Fluoride/Sodium Hexametaphosphate/ZincLactate Dentifrice, and a Sodium Fluoride Dentifrice for theControl of Established Supragingival Plaque and Gingivitis:A Six-Week Clinical Study............................................................................111

Farid Ayad, Bernal Stewart, Yun Po Zhang,

Howard M. Proskin

Comparative Investigation of the Efficacy of Triclosan/Copolymer/Sodium Fluoride and Stannous Fluoride/Sodium Hexametaphosphate/Zinc Lactate Dentifrices for the Control of Established SupragingivalPlaque and Gingivitis in a Six-Month Clinical Study ................................117

Augusto Elias Boneta, Mauricio Montero Aguilar,

Ferdinand Lugo Romeu, Bernal Stewart,

William DeVizio, Howard M. Proskin

Documents

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